National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2012-07-24
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 02:34:07

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0469-6501-89	ML - Milliliter	0469-6501	bbfc4547-9748-4506-b7bf-1ca3099db9a2	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0469-6501	0469-6501-89

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022161-001	LEXISCAN	REGADENOSON	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022161-001	AP

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022161-001	8106183	2027-02-02		Drug substance	2012-03-08
N022161-001	RE47301	2027-02-02		Drug product	2019-04-02

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 2 · 43 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
2026-09-14 22:38:34	2026-08	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-04-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-04-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-04-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-04-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-04-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-04-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-04-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-04-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-04-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-04-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-04-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2008-04-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022161-001	LEXISCAN	0.4MG/5ML (0.08MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2008-04-10	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N022161-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022161-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022161-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022161-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022161-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022161-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022161-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022161-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022161-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022161-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022161-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022161-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022161-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022161-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022161-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022161-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022161-001	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022161-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022161-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022161-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022161-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022161-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022161-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022161-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022161-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022161-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022161-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022161-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022161-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022161-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022161-001	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022161-001	8106183	2027-02-02		Drug substance	2012-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022161-001	RE47301	2027-02-02		Drug product	2019-04-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022161-001	8106183	2027-02-02		Drug substance	2012-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022161-001	RE47301	2027-02-02		Drug product	2019-04-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022161-001	8106183	2027-02-02		Drug substance	2012-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022161-001	RE47301	2027-02-02		Drug product	2019-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022161-001	8106183	2027-02-02		Drug substance	2012-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022161-001	RE47301	2027-02-02		Drug product	2019-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022161-001	8106183	2027-02-02		Drug substance	2012-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022161-001	RE47301	2027-02-02		Drug product	2019-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022161-001	8106183	2027-02-02		Drug substance	2012-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022161-001	RE47301	2027-02-02		Drug product	2019-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022161-001	8106183	2027-02-02		Drug substance	2012-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022161-001	RE47301	2027-02-02		Drug product	2019-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022161-001	8106183	2027-02-02		Drug substance	2012-03-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022161-001	RE47301	2027-02-02		Drug product	2019-04-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022161-001	8106183	2027-02-02		Drug substance	2012-03-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022161-001	RE47301	2027-02-02		Drug product	2019-04-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022161-001	8106183	2027-02-02		Drug substance	2012-03-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022161-001	RE47301	2027-02-02		Drug product	2019-04-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022161-001	8106183	2027-02-02		Drug substance	2012-03-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022161-001	RE47301	2027-02-02		Drug product	2019-04-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022161-001	8106183	2027-02-02		Drug substance	2012-03-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022161-001	RE47301	2027-02-02		Drug product	2019-04-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022161-001	8106183	2027-02-02		Drug substance	2012-03-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022161-001	RE47301	2027-02-02		Drug product	2019-04-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022161-001	8106183	2027-02-02		Drug substance	2012-03-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022161-001	RE47301	2027-02-02		Drug product	2019-04-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022161-001	8106183	2027-02-02		Drug substance	2012-03-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022161-001	RE47301	2027-02-02		Drug product	2019-04-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022161-001	8106183	2027-02-02		Drug substance	2012-03-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022161-001	RE47301	2027-02-02		Drug product	2019-04-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022161-001	6403567	2022-04-10	U-869	Drug substance, Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022161-001	8106183	2027-02-02		Drug substance	2012-03-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022161-001	RE47301	2027-02-02		Drug product	2019-04-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022161-001	6403567	2022-04-10	U-869	Drug substance, Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022161-001	8106183	2027-02-02		Drug substance	2012-03-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022161-001	RE47301	2027-02-02		Drug product	2019-04-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022161-001	6403567	2022-04-10	U-869	Drug substance, Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022161-001	8106183	2027-02-02		Drug substance	2012-03-08	`4b0b4de00fa7…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022161-001	M-194	2020-01-17	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N022161-001	M-194	2020-01-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022161-001	M-194	2020-01-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022161-001	M-194	2020-01-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022161-001	M-194	2020-01-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022161-001	M-194	2020-01-17	`ea99ee380514…`

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
LEXISCAN	REGADENOSON	Astellas Pharma US, Inc.	057289f4-2e18-4c1e-bed4-6c1858e2ef16	2018-12-21	Warnings, Adverse reactions	Exact identifier ndc (package): 0469-6501-89 ndc11 (package): 00469650189

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.