Terbutaline Sulfate

Product NDC: 10135-579
11-digit product format: 101350579
Labeler code: 10135
Product ID: 10135-579_500ad3da-ce1b-4289-acdd-be3ec36577fb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Terbutaline Sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA077152
Marketing category: ANDA
Marketing start: 2014-10-01
Marketing end: 0000-00-00
Substance: TERBUTALINE SULFATE
Active strength: 3 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10135-579		I	Inactivated by FDA	2026-08-17
excluded package	package	10135-579	10135-579-01	I	Inactivated by FDA	2026-08-17
excluded package	package	10135-579	10135-579-10	I	Inactivated by FDA	2026-08-17
excluded package	package	10135-579	10135-579-32	I	Inactivated by FDA	2026-08-17

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 2 · 76 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-579-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-579-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-579-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-579-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-579-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-579-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-579-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-579-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-579-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-579-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-579-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-579-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-579-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-579-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-579-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-579-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-579-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-579-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-579-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-579-32	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-579-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-579-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-579-32	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-579-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-579-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-579-32	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-579-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-579-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-579-32	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-579-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-579-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-579-32	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-579-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-579-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-579-32	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-579-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-579-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-579-32	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-579-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-579-10	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-579-32	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-579-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-579-10	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-579-32	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-579-01	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077152-001	TERBUTALINE SULFATE	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25
A077152-002	TERBUTALINE SULFATE	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077152-001	AB
A077152-002	AB

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 · 84 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
2026-08-18 06:07:40	2026-07	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077152-001	TERBUTALINE SULFATE	2.5MG	TABLET / ORAL	AB		2005-03-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077152-002	TERBUTALINE SULFATE	5MG	TABLET / ORAL	AB	RS	2005-03-25	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077152-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077152-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077152-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077152-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077152-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077152-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077152-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077152-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077152-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077152-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077152-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077152-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077152-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077152-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077152-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077152-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077152-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077152-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077152-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077152-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077152-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077152-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077152-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077152-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077152-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077152-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077152-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077152-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077152-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077152-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077152-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077152-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077152-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077152-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077152-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077152-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077152-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077152-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077152-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077152-002	AB	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
49ccb555-d142-0761-ee45-2e1304b37b1d	Product name	2	20210111
a3c04a67-87ea-e8b8-0458-db8085ac6340	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10135-579-01	2022-01-28	C162847	48780-1	d6a99b39-517a-a426-e053-dadaa90af4c2	Terbutaline Sulfate Tablets, USP
10135-579-10	2022-01-28	C162847	48780-1	d6a99b39-517a-a426-e053-dadaa90af4c2	Terbutaline Sulfate Tablets, USP
10135-579-32	2022-01-28	C162847	48780-1	d6a99b39-517a-a426-e053-dadaa90af4c2	Terbutaline Sulfate Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10135-579-01	Terbutaline Sulfate	100 in 1 BOTTLE	TABLET	100	3
10135-579-10	Terbutaline Sulfate	1000 in 1 BOTTLE	TABLET	1000	3
10135-579-32	Terbutaline Sulfate	180 in 1 BOTTLE	TABLET	180	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-579-01	EA - Each	10135-579	75cce4ea-5a04-4e32-a0cc-1dcf1e49ffa5	1	2015-04-03
10135-579-32	EA - Each	10135-579	aefe59ff-9284-4d85-a9e7-926f6b4e11f4	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TERBUTALINE SULFATE	ACTIVE INGREDIENT	576PU70Y8E	TERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]	1
TERBUTALINE	ACTIVE MOIETY	N8ONU3L3PG	TERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-579	TERBUTALINE SULFATE TABLET [MARLEX PHARMACEUTICALS INC]	3	Legacy NDC, 3 package rows	20200107_94742710-e87e-4e1c-85ee-0a2e7a77f0de.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terbutaline Sulfate	TERBUTALINE SULFATE	Chartwell RX, LLC.	859267c6-3d14-4123-9b9d-4fc248f09726	2025-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077152 application number: ANDA077152
Terbutaline Sulfate	TERBUTALINE SULFATE	Lannett Company, Inc.	fbf54709-5857-4dbc-9233-ebd7abff88c8	2020-11-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077152 application number: ANDA077152

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
576PU70Y8E	TERBUTALINE SULFATE	23031-32-5	TERBUTALINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857677	terbutaline sulfate 2.5 MG Oral Tablet	PSN	94742710-e87e-4e1c-85ee-0a2e7a77f0de	3
857683	terbutaline sulfate 5 MG Oral Tablet	PSN	94742710-e87e-4e1c-85ee-0a2e7a77f0de	3
857677	terbutaline sulfate 2.5 MG Oral Tablet	SCD	94742710-e87e-4e1c-85ee-0a2e7a77f0de	3
857683	terbutaline sulfate 5 MG Oral Tablet	SCD	94742710-e87e-4e1c-85ee-0a2e7a77f0de	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10135-579-01	10135057901	100 TABLET in 1 BOTTLE (10135-579-01)	100 tablet	2014-10-01	0000-00-00	No	No	Current
10135-579-10	10135057910	1000 TABLET in 1 BOTTLE (10135-579-10)	1000 tablet	2014-10-01	0000-00-00	No	No	Current
10135-579-32	10135057932	180 TABLET in 1 BOTTLE (10135-579-32)	180 tablet	2014-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Terbutaline Sulfate Tablets, USP	Marlex Pharmaceuticals Inc	2020-01-09	HUMAN PRESCRIPTION DRUG LABEL	3