Nifedipine

Product NDC: 72162-2535
Requested package NDC: 72162-2535-1
11-digit product format: 721622535
Labeler code: 72162
Product ID: 72162-2535_9205be3f-c95c-4653-83a8-92ddd6398523
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nifedipine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA213361
Marketing category: ANDA
Marketing start: 2021-07-19
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
A213361-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19
A213361-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19
A213361-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213361-001	AB1
A213361-002	AB1
A213361-003	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 3 · 99 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	A213361-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213361-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213361-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213361-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213361-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213361-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213361-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213361-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213361-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213361-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213361-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213361-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213361-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213361-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213361-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213361-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213361-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213361-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213361-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213361-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213361-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213361-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213361-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213361-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213361-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213361-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213361-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213361-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213361-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213361-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213361-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213361-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213361-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213361-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213361-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213361-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213361-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213361-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213361-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213361-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2021-07-19	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 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	A213361-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213361-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213361-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213361-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213361-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213361-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213361-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213361-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213361-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213361-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213361-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213361-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213361-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213361-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213361-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213361-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213361-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213361-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213361-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213361-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213361-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213361-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213361-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213361-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213361-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213361-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213361-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213361-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213361-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213361-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213361-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213361-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213361-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213361-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213361-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213361-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213361-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213361-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213361-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213361-001	AB1	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
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
5432254e-ce27-4a67-9eba-e06e092cb93d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bbd94e90-e531-9113-45c1-29860f331640	Product name	7	20230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffd	Product name	4	20220126
308fd2ea-d88a-e021-96c1-7c2ab74d6e4b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72162-2535-1	Nifedipine	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-2535-1	EA - Each	72162-2535	dd4febc8-e376-49b2-8c29-f7d077871ddd	1	2025-10-14

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Redpharm Drug	3b0ae3ed-77ee-d0df-e063-6294a90a7d17	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213361 application number: ANDA213361
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	5432254e-ce27-4a67-9eba-e06e092cb93d	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213361 application number: ANDA213361 ndc (package): 72162-2535-1 ndc (product): 72162-2535 ndc11 (package): 72162253501
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	7dc5eec6-f32a-45e6-af24-830738cae471	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213361 application number: ANDA213361
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	1bd05e73-5104-4ef7-a705-22e2db140354	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213361 application number: ANDA213361
Nifedipine	NIFEDIPINE	Aurobindo Pharma Limited	eb70b7ff-f9f0-41d0-901a-f4c04ae9ed46	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213361 application number: ANDA213361
Nifedipine	NIFEDIPINE	NuCare Pharmaceuticals,Inc.	27d6c9c5-5a45-9cfc-e063-6394a90a7202	2024-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213361 application number: ANDA213361

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	5432254e-ce27-4a67-9eba-e06e092cb93d	100
198035	24 HR nifedipine 60 MG Extended Release Oral Tablet	SCD	5432254e-ce27-4a67-9eba-e06e092cb93d	100
198035	nifedipine 60 MG 24 HR Extended Release Oral Tablet	SY	5432254e-ce27-4a67-9eba-e06e092cb93d	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72162-2535-1	72162253501	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2535-1)	2025-09-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nifedipine Extended-Release Tablets, USP For Oral Use Rx only	Bryant Ranch Prepack	2025-09-19	HUMAN PRESCRIPTION DRUG LABEL	100