Nifedipine

Product NDC: 51655-780
11-digit product format: 516550780
Labeler code: 51655
Product ID: 51655-780_497391b6-a374-ab61-e063-6394a90a762c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nifedipine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA202987
Marketing category: ANDA
Marketing start: 2021-08-02
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: 2027-12-31
Current FDA listing: Yes

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

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	RLD / RS	Approval date
A202987-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25
A202987-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25
A202987-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202987-001	AB1
A202987-002	AB1
A202987-003	AB1

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 4 · 126 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	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202987-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202987-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	2016-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202987-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-08-25	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A202987-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202987-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202987-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202987-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202987-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202987-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202987-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202987-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202987-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202987-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202987-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202987-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202987-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202987-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202987-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202987-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202987-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202987-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202987-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202987-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202987-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202987-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202987-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202987-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202987-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202987-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202987-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202987-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202987-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202987-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202987-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202987-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202987-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202987-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202987-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202987-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202987-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202987-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202987-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202987-001	AB1	1	`1e350fbaab3a…`

Additional Listing Data#

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

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
198035	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
da80fa84-9336-082c-e053-2a95a90a8987	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	Strength	SPL version
51655-780-52	Nifedipine	30 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-780	NIFEDIPINE TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS]	1	Current NDC, 1 package rows	20230221_da80fa84-9336-082c-e053-2a95a90a8987.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Golden State Medical Supply, Inc.	d9a501be-8523-3924-e053-2995a90a8569	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202987 application number: ANDA202987
Nifedipine	NIFEDIPINE	Ingenus Pharmaceuticals, LLC	4d02eba2-e964-4fa7-aaae-25949b5f0316	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202987 application number: ANDA202987
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	da80fa84-9336-082c-e053-2a95a90a8987	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202987 application number: ANDA202987 ndc (product): 51655-780
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	1b98b011-793c-ed92-e063-6294a90ac2bc	2024-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202987 application number: ANDA202987
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	75bb3a1f-3cb7-4450-8e59-27521a1ebc25	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202987 application number: ANDA202987

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
198035	NIFEdipine 60 MG 24HR Extended Release Oral Tablet	PSN	da80fa84-9336-082c-e053-2a95a90a8987	2
198035	24 HR nifedipine 60 MG Extended Release Oral Tablet	SCD	da80fa84-9336-082c-e053-2a95a90a8987	2
198035	nifedipine 60 MG 24 HR Extended Release Oral Tablet	SY	da80fa84-9336-082c-e053-2a95a90a8987	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
51655-780-52	51655078052	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-780-52)	2021-08-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nifedipine Extended-Release Tablets, USP 60mg	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	2