Nifedipine

Product NDC: 50742-260
11-digit product format: 507420260
Labeler code: 50742
Product ID: 50742-260_2d798366-5fb6-4ea5-b1cc-663a0c3290b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nifedipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Ingenus Pharmaceuticals, LLC
Application: ANDA210614
Marketing category: ANDA
Marketing start: 2019-03-12
Substance: NIFEDIPINE
Active strength: 30 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 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	RLD / RS	Approval date
A210614-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12
A210614-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12
A210614-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2019-03-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210614-001	AB2
A210614-002	AB2
A210614-003	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 4 · 123 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	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2019-03-12	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A210614-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210614-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210614-003	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210614-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210614-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210614-003	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210614-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210614-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210614-003	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210614-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210614-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210614-003	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210614-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210614-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210614-003	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210614-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210614-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210614-003	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210614-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210614-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210614-003	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210614-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210614-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210614-003	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210614-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210614-002	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210614-003	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210614-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210614-002	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210614-003	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210614-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210614-002	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210614-003	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210614-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210614-002	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210614-003	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210614-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210614-002	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210614-003	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210614-001	AB2	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NIFEDIPINE	30 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1812011	Internal RxNorm lookup
1812013	Internal RxNorm lookup
1812015	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
4d3e11d2-d320-45d3-96c8-48322202b504	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	SPL version
50742-260-01	Nifedipine	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	6
50742-260-03	Nifedipine	300 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	300	6
50742-260-30	Nifedipine	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50742-260-01	EA - Each	50742-260	ba66fc7a-5e00-4d3f-b83a-0cb8a597a14e	1	2019-04-11
50742-260-03	EA - Each	50742-260	efbd0da5-df8b-4572-9c46-e65f3ea625fe	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50742-260	NIFEDIPINE TABLET, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC]	4	Current NDC, Legacy NDC, 3 package rows	20230207_4d3e11d2-d320-45d3-96c8-48322202b504.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	St. Mary's Medical Park Pharmacy	1add684f-d082-72cc-e063-6394a90a1214	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614
Nifedipine	NIFEDIPINE	St. Mary's Medical Park Pharmacy	1ab8945b-bea5-9827-e063-6294a90af334	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	e1cd5011-b80e-4b1b-8729-56260b8b3c26	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614
Nifedipine	NIFEDIPINE	Coupler LLC	518d39af-0be1-acbc-e063-6294a90a4ada	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614
Nifedipine	NIFEDIPINE	Major Pharmaceuticals	41aa6fbd-96c1-40f7-92d4-cfdd2d5325e9	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614
Nifedipine	NIFEDIPINE	Ingenus Pharmaceuticals, LLC	4d3e11d2-d320-45d3-96c8-48322202b504	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614 ndc (product): 50742-260
Nifedipine	NIFEDIPINE	Cardinal Health 107, LLC	c98ecf77-ae9a-438b-9bad-ffbed25d95bc	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614
Nifedipine	NIFEDIPINE	A-S Medication Solutions	446505e8-cd68-4037-bebe-954a893dc67b	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614
Nifedipine	NIFEDIPINE	A-S Medication Solutions	3334ab6f-aeb0-4b78-8d17-f0aedd94f996	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614
Nifedipine	NIFEDIPINE	REMEDYREPACK INC.	24e56333-5601-48fd-a263-f6be90983fb4	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	f8358be1-848c-d9eb-e053-6294a90a178c	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	f2f3564a-d43a-6c36-e053-2a95a90ae878	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	f32c0fc9-b4ad-6a1f-e053-2995a90acf61	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614
Nifedipine	NIFEDIPINE	A-S Medication Solutions	9f64a8d7-dfbf-4a81-81bd-b09cfe7cbd44	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614
Nifedipine	NIFEDIPINE	Preferred Pharmaceuticals Inc.	cda16a27-f029-40a6-a0e8-2bed0de71169	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614
Nifedipine	NIFEDIPINE	Preferred Pharmaceuticals, Inc.	4ee466dc-5a4e-4c77-8e94-8b510cafd61b	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614
Nifedipine	NIFEDIPINE	REMEDYREPACK INC.	832fc274-605a-4b04-b327-dbf361131621	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	325acf27-4b2e-40e8-8344-bb6cc9959910	2025-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614
Nifedipine	NIFEDIPINE	NuCare Pharmaceuticals,Inc.	d5df10bc-16ed-7a97-e053-2a95a90ab15e	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614
Nifedipine	NIFEDIPINE	NCS HealthCare of KY, LLC dba Vangard Labs	0cabe053-3b7e-4dcb-8441-ef7821bb6f68	2024-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614

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
1812011	NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet	PSN	24e56333-5601-48fd-a263-f6be90983fb4	10
1812011	Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet	SCD	24e56333-5601-48fd-a263-f6be90983fb4	10
1812011	nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet	SY	24e56333-5601-48fd-a263-f6be90983fb4	10
1812011	NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet	PSN	4ee466dc-5a4e-4c77-8e94-8b510cafd61b	6
1812011	NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet	PSN	4d3e11d2-d320-45d3-96c8-48322202b504	6
1812013	NIFEdipine 60 MG Osmotic 24HR Extended Release Oral Tablet	PSN	4d3e11d2-d320-45d3-96c8-48322202b504	6
1812015	NIFEdipine 90 MG Osmotic 24HR Extended Release Oral Tablet	PSN	4d3e11d2-d320-45d3-96c8-48322202b504	6
1812011	Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet	SCD	4d3e11d2-d320-45d3-96c8-48322202b504	6
1812011	Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet	SCD	4ee466dc-5a4e-4c77-8e94-8b510cafd61b	6
1812013	Osmotic 24 HR nifedipine 60 MG Extended Release Oral Tablet	SCD	4d3e11d2-d320-45d3-96c8-48322202b504	6
1812015	Osmotic 24 HR nifedipine 90 MG Extended Release Oral Tablet	SCD	4d3e11d2-d320-45d3-96c8-48322202b504	6
1812011	nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet	SY	4d3e11d2-d320-45d3-96c8-48322202b504	6
1812011	nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet	SY	4ee466dc-5a4e-4c77-8e94-8b510cafd61b	6
1812013	nifedipine 60 MG Osmotic 24 HR Extended Release Oral Tablet	SY	4d3e11d2-d320-45d3-96c8-48322202b504	6
1812015	nifedipine 90 MG Osmotic 24 HR Extended Release Oral Tablet	SY	4d3e11d2-d320-45d3-96c8-48322202b504	6
1812011	NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet	PSN	3334ab6f-aeb0-4b78-8d17-f0aedd94f996	5
1812011	NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet	PSN	325acf27-4b2e-40e8-8344-bb6cc9959910	5
1812011	Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet	SCD	325acf27-4b2e-40e8-8344-bb6cc9959910	5
1812011	Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet	SCD	3334ab6f-aeb0-4b78-8d17-f0aedd94f996	5
1812011	nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet	SY	325acf27-4b2e-40e8-8344-bb6cc9959910	5
1812011	nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet	SY	3334ab6f-aeb0-4b78-8d17-f0aedd94f996	5
1812011	NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet	PSN	f32c0fc9-b4ad-6a1f-e053-2995a90acf61	3
1812011	Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet	SCD	f32c0fc9-b4ad-6a1f-e053-2995a90acf61	3
1812011	nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet	SY	f32c0fc9-b4ad-6a1f-e053-2995a90acf61	3
1812011	NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet	PSN	d5df10bc-16ed-7a97-e053-2a95a90ab15e	2
1812011	Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet	SCD	d5df10bc-16ed-7a97-e053-2a95a90ab15e	2
1812011	nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet	SY	d5df10bc-16ed-7a97-e053-2a95a90ab15e	2
1812011	NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet	PSN	518d39af-0be1-acbc-e063-6294a90a4ada	1
1812011	Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet	SCD	518d39af-0be1-acbc-e063-6294a90a4ada	1
1812011	nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet	SY	518d39af-0be1-acbc-e063-6294a90a4ada	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50742-260-01	50742026001	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50742-260-01)	2019-03-12	0000-00-00	No	No	Current
50742-260-03	50742026003	300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50742-260-03)	2019-03-12	0000-00-00	No	No	Current
50742-260-30	50742026030	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50742-260-30)	2019-03-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nifedipine Extended -release Tablets, USP For Oral Use	Coupler LLC \| Novast Laboratories, Ltd.	2026-05-11	HUMAN PRESCRIPTION DRUG LABEL	1
Nifedipine Extended -release Tablets, USP For Oral Use	Major Pharmaceuticals	2026-04-30	HUMAN PRESCRIPTION DRUG LABEL	7
Nifedipine Extended -release Tablets, USP For Oral Use	Ingenus Pharmaceuticals, LLC \| Novast Laboratories, Ltd.	2026-03-30	HUMAN PRESCRIPTION DRUG LABEL	6
Nifedipine Extended -release Tablets, USP For Oral Use	A-S Medication Solutions	2026-02-11	HUMAN PRESCRIPTION DRUG LABEL	5
Nifedipine Extended -release Tablets, USP For Oral Use	REMEDYREPACK INC.	2026-02-10	HUMAN PRESCRIPTION DRUG LABEL	10
Nifedipine Extended -release Tablets, USP For Oral Use	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Nifedipine Extended -release Tablets, USP For Oral Use	Preferred Pharmaceuticals, Inc.	2025-08-19	HUMAN PRESCRIPTION DRUG LABEL	6
Nifedipine Extended -release Tablets, USP For Oral Use	Bryant Ranch Prepack	2025-03-27	HUMAN PRESCRIPTION DRUG LABEL	5
Nifedipine Extended -release Tablets, USP For Oral Use	NuCare Pharmaceuticals,Inc.	2024-12-24	HUMAN PRESCRIPTION DRUG LABEL	2