Letairis

Product NDC: 61958-0801
11-digit product format: 619580801
Labeler code: 61958
Product ID: 61958-0801_273ba426-0edb-47a2-b5d3-883cd1b9369a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMBRISENTAN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Gilead Sciences, Inc.
Application: NDA022081
Marketing category: NDA
Marketing start: 2007-06-15
Substance: AMBRISENTAN
Active strength: 5 mg/1
Pharmacologic classes: Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 28 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61958-0801-5	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61958-0801-6	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61958-0801-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61958-0801-2	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61958-0801-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61958-0801-4	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61958-0801-5	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61958-0801-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61958-0801-2	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61958-0801-6	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61958-0801-4	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61958-0801-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61958-0801-5	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61958-0801-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61958-0801-2	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61958-0801-6	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61958-0801-4	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61958-0801-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61958-0801-5	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61958-0801-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61958-0801-2	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61958-0801-6	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61958-0801-4	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61958-0801-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022081-001	LETAIRIS	AMBRISENTAN	5MG	TABLET / ORAL	AB	RLD	2007-06-15
N022081-002	LETAIRIS	AMBRISENTAN	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022081-001	AB
N022081-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022081-001	8377933	2027-12-11	U-1754	2015-10-23
N022081-001	9474752	2027-12-11	U-1754	2016-11-23
N022081-001	9549926	2031-10-14	U-1965	2017-02-16
N022081-002	8377933	2027-12-11	U-1754	2015-10-23
N022081-002	9474752	2027-12-11	U-1754	2016-11-23
N022081-002	9549926	2031-10-14	U-1965	2017-02-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022081-001	LETAIRIS	5MG	TABLET / ORAL	AB	RLD	2007-06-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022081-002	LETAIRIS	10MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022081-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022081-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022081-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022081-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022081-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022081-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022081-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022081-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022081-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022081-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022081-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022081-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022081-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022081-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022081-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022081-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022081-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022081-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022081-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022081-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022081-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022081-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022081-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022081-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022081-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022081-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022081-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022081-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022081-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022081-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022081-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022081-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022081-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022081-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022081-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022081-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022081-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022081-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022081-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022081-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022081-001	8377933	2027-12-11	U-1754	2015-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022081-001	9474752	2027-12-11	U-1754	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022081-001	9549926	2031-10-14	U-1965	2017-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022081-002	8377933	2027-12-11	U-1754	2015-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022081-002	9474752	2027-12-11	U-1754	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022081-002	9549926	2031-10-14	U-1965	2017-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022081-001	8377933	2027-12-11	U-1754	2015-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022081-001	9474752	2027-12-11	U-1754	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022081-001	9549926	2031-10-14	U-1965	2017-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022081-002	8377933	2027-12-11	U-1754	2015-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022081-002	9474752	2027-12-11	U-1754	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022081-002	9549926	2031-10-14	U-1965	2017-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022081-001	8377933	2027-12-11	U-1754	2015-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022081-001	9474752	2027-12-11	U-1754	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022081-001	9549926	2031-10-14	U-1965	2017-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022081-002	8377933	2027-12-11	U-1754	2015-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022081-002	9474752	2027-12-11	U-1754	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022081-002	9549926	2031-10-14	U-1965	2017-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022081-001	8377933	2027-12-11	U-1754	2015-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022081-001	9474752	2027-12-11	U-1754	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022081-001	9549926	2031-10-14	U-1965	2017-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022081-002	8377933	2027-12-11	U-1754	2015-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022081-002	9474752	2027-12-11	U-1754	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022081-002	9549926	2031-10-14	U-1965	2017-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022081-001	8377933	2027-12-11	U-1754	2015-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022081-001	9474752	2027-12-11	U-1754	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022081-001	9549926	2031-10-14	U-1965	2017-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022081-002	8377933	2027-12-11	U-1754	2015-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022081-002	9474752	2027-12-11	U-1754	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022081-002	9549926	2031-10-14	U-1965	2017-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022081-001	8377933	2027-12-11	U-1754	2015-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022081-001	9474752	2027-12-11	U-1754	2016-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022081-001	9549926	2031-10-14	U-1965	2017-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022081-002	8377933	2027-12-11	U-1754	2015-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022081-002	9474752	2027-12-11	U-1754	2016-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022081-002	9549926	2031-10-14	U-1965	2017-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022081-001	8377933	2027-12-11	U-1754	2015-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022081-001	9474752	2027-12-11	U-1754	2016-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022081-001	9549926	2031-10-14	U-1965	2017-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022081-002	8377933	2027-12-11	U-1754	2015-10-23	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Letairis
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMBRISENTAN	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
HW6NV07QEC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
722116	Internal RxNorm lookup
722120	Internal RxNorm lookup
722122	Internal RxNorm lookup
722124	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
725d4e73-6c83-477a-adc6-0ae4a133a844	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
d7db2b61-402f-f2c9-6e9c-10d81037d0ba	Product name	3	20230126
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
61958-0801-1	2025-08-26	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-1	2025-08-26	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-2	2025-08-26	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-2	2025-08-26	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-3	2025-08-26	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-3	2025-08-26	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-4	2025-08-26	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-4	2025-08-26	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-5	2025-08-26	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-5	2025-08-26	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-6	2025-08-26	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-6	2025-08-26	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-1	2025-07-29	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-1	2025-07-29	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-2	2025-07-29	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-2	2025-07-29	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-3	2025-07-29	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-3	2025-07-29	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-4	2025-07-29	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-4	2025-07-29	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-5	2025-07-29	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-5	2025-07-29	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-6	2025-07-29	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-6	2025-07-29	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-1	2025-02-14	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-1	2025-02-14	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-2	2025-02-14	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-2	2025-02-14	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-3	2025-02-14	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-3	2025-02-14	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-4	2025-02-14	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-4	2025-02-14	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-5	2025-02-14	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-5	2025-02-14	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-6	2025-02-14	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-6	2025-02-14	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-1	2025-01-30	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-1	2025-01-30	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-2	2025-01-30	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-2	2025-01-30	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-3	2025-01-30	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-3	2025-01-30	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-4	2025-01-30	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-4	2025-01-30	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-5	2025-01-30	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-5	2025-01-30	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-6	2025-01-30	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007
61958-0801-6	2025-01-30	These highlights do not include all the information needed to use LETAIRIS ® safely and effectively. See full prescribing information for LETAIRIS. Letairis (ambrisentan) tablets, for oral use Initial U.S. Approval: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61958-0801-1	Letairis	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	27
61958-0801-2	Letairis	3 in 1 CARTON	TABLET, FILM COATED	3	27
61958-0801-2	Letairis	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	27
61958-0801-3	Letairis	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	27
61958-0801-3	Letairis	1 in 1 CARTON	TABLET, FILM COATED	1	27
61958-0801-4	Letairis	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	27
61958-0801-4	Letairis	1 in 1 CARTON	TABLET, FILM COATED	1	27
61958-0801-5	Letairis	10 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	10	27
61958-0801-6	Letairis	10 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	10	27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61958-0801-1	EA - Each	61958-0801	3ea7295c-ef90-4822-8401-2e857e5b7288	1	2013-08-02
61958-0801-2	EA - Each	61958-0801	8e81ffb7-bfe7-4ab6-ae49-efa72649ddfc	1	2012-07-24
61958-0801-3	EA - Each	61958-0801	489ffd10-5506-4a24-91f9-f4f6b883c346	1	2013-02-13
61958-0801-5	EA - Each	61958-0801	5e30fce9-e6c9-4b8d-a9d3-d5af68e9745d	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMBRISENTAN	ACTIVE INGREDIENT	HW6NV07QEC	LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]	20
AMBRISENTAN	ACTIVE MOIETY	HW6NV07QEC	LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]	20
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]	20
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]	20
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]	20
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]	20
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]	20
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]	20
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]	20
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]	20
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]	20
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]	20
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]	20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61958-0801	LETAIRIS (AMBRISENTAN) TABLET, FILM COATED [GILEAD SCIENCES, INC]	26	Current NDC, Legacy NDC, 9 package rows	20250427_725d4e73-6c83-477a-adc6-0ae4a133a844.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Letairis	AMBRISENTAN	Gilead Sciences, Inc.	725d4e73-6c83-477a-adc6-0ae4a133a844	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022081 application number: NDA022081 ndc (product): 61958-0801

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HW6NV07QEC	AMBRISENTAN	177036-94-1	AMBRISENTAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
722116	ambrisentan 10 MG Oral Tablet	PSN	725d4e73-6c83-477a-adc6-0ae4a133a844	27
722122	ambrisentan 5 MG Oral Tablet	PSN	725d4e73-6c83-477a-adc6-0ae4a133a844	27
722120	Letairis 10 MG Oral Tablet	PSN	725d4e73-6c83-477a-adc6-0ae4a133a844	27
722124	Letairis 5 MG Oral Tablet	PSN	725d4e73-6c83-477a-adc6-0ae4a133a844	27
722120	ambrisentan 10 MG Oral Tablet [Letairis]	SBD	725d4e73-6c83-477a-adc6-0ae4a133a844	27
722124	ambrisentan 5 MG Oral Tablet [Letairis]	SBD	725d4e73-6c83-477a-adc6-0ae4a133a844	27
722116	ambrisentan 10 MG Oral Tablet	SCD	725d4e73-6c83-477a-adc6-0ae4a133a844	27
722122	ambrisentan 5 MG Oral Tablet	SCD	725d4e73-6c83-477a-adc6-0ae4a133a844	27
722120	Letairis 10 MG Oral Tablet	SY	725d4e73-6c83-477a-adc6-0ae4a133a844	27
722124	Letairis 5 MG Oral Tablet	SY	725d4e73-6c83-477a-adc6-0ae4a133a844	27

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61958-0801-1	61958080101	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-1)		2007-06-15	0000-00-00	No	No	Current
61958-0801-2	61958080102	3 BLISTER PACK in 1 CARTON (61958-0801-2) / 10 TABLET, FILM COATED in 1 BLISTER PACK	3 blister pack	2007-06-15	0000-00-00	No	No	Current
61958-0801-3	61958080103	1 BLISTER PACK in 1 CARTON (61958-0801-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2007-06-15	0000-00-00	No	No	Current
61958-0801-4	61958080104	1 BLISTER PACK in 1 CARTON (61958-0801-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2007-06-15	0000-00-00	No	No	Current
61958-0801-5	61958080105	10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-5)		2007-06-15	0000-00-00	No	No	Current
61958-0801-6	61958080106	10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0801-6)		2007-06-15	0000-00-00	No	No	Current