Nifedipine

Product NDC: 50090-6767
11-digit product format: 500906767
Labeler code: 50090
Product ID: 50090-6767_db03e3bc-412a-4336-a97c-dbcdb4bbc1bc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nifedipine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA216067
Marketing category: ANDA
Marketing start: 2022-03-30
Substance: NIFEDIPINE
Active strength: 60 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A216067-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29
A216067-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29
A216067-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A216067-001	AB2
A216067-002	AB2
A216067-003	AB2

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 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216067-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216067-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216067-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2022-03-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 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	A216067-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216067-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216067-003	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216067-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216067-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216067-003	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216067-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216067-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216067-003	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216067-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216067-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216067-003	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216067-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216067-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216067-003	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216067-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216067-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216067-003	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216067-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216067-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216067-003	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216067-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216067-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216067-003	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216067-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216067-002	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216067-003	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216067-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216067-002	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216067-003	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216067-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216067-002	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216067-003	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216067-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216067-002	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216067-003	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216067-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216067-002	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216067-003	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216067-001	AB2	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nifedipine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NIFEDIPINE	60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
I9ZF7L6G2L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1812013	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
4a4d5b67-6ce7-4098-9324-f68084e800e4	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
bbd94e90-e531-9113-45c1-29860f331640	Product name	7	20230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffd	Product name	4	20220126
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
308fd2ea-d88a-e021-96c1-7c2ab74d6e4b	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-6767-0	Nifedipine	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	3
50090-6767-1	Nifedipine	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	3
50090-6767-2	Nifedipine	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6767-0	EA - Each	50090-6767	c34d8501-8557-47a7-a86f-799bc9d50c37	1	2023-12-05
50090-6767-1	EA - Each	50090-6767	9c3ba156-84c9-42c5-a6b9-95c8d63f7d10	1	2023-12-05
50090-6767-2	EA - Each	50090-6767	feb9a991-629c-40bd-84e1-f870de38f3f7	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6767	NIFEDIPINE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]	3	Current NDC, 3 package rows	20231031_4a4d5b67-6ce7-4098-9324-f68084e800e4.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	7160331a-8735-4bc0-8cb9-a8014512a669	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216067 application number: ANDA216067
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	89723620-474e-4b16-9f57-4e927efc401c	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216067 application number: ANDA216067
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	8e5e126a-7da6-4ceb-b72b-5c9dcc7d7769	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216067 application number: ANDA216067
Nifedipine	NIFEDIPINE	A-S Medication Solutions	5a7951e7-f507-43e8-9bba-855b79daf170	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216067 application number: ANDA216067
Nifedipine	NIFEDIPINE	Redpharm Drug	32526983-f53a-fa68-e063-6394a90aa13f	2025-12-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216067 application number: ANDA216067
Nifedipine	NIFEDIPINE	Ascend Laboratories, LLC	f661c1d9-f0f6-4595-82dd-f656bff974f1	2025-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216067 application number: ANDA216067
Nifedipine	NIFEDIPINE	A-S Medication Solutions	4a4d5b67-6ce7-4098-9324-f68084e800e4	2023-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216067 application number: ANDA216067 ndc (product): 50090-6767

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I9ZF7L6G2L	NIFEDIPINE	21829-25-4	NIFEDIPINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1812013	NIFEdipine 60 MG Osmotic 24HR Extended Release Oral Tablet	PSN	4a4d5b67-6ce7-4098-9324-f68084e800e4	3
1812013	Osmotic 24 HR nifedipine 60 MG Extended Release Oral Tablet	SCD	4a4d5b67-6ce7-4098-9324-f68084e800e4	3
1812013	nifedipine 60 MG Osmotic 24 HR Extended Release Oral Tablet	SY	4a4d5b67-6ce7-4098-9324-f68084e800e4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-6767-0	50090676700	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6767-0)	2023-10-20	No	No	Current
50090-6767-1	50090676701	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6767-1)	2023-10-20	No	No	Current
50090-6767-2	50090676702	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6767-2)	2023-10-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nifedipine Extended-Release Tablets For Oral Use	A-S Medication Solutions	2023-10-30	Human Prescription Drug Label	3