Nifedipine

Product NDC: 70518-4625
Requested package NDC: 70518-4625-0
11-digit product format: 705184625
Labeler code: 70518
Product ID: 70518-4625_503ac20c-0b86-83cf-e063-6294a90a0ee7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nifedipine
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA202644
Marketing category: ANDA
Marketing start: 2026-04-24
Substance: NIFEDIPINE
Active strength: 10 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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202644-001	NIFEDIPINE	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	RS	2013-04-25
A202644-002	NIFEDIPINE	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202644-001	AB
A202644-002	AB

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 · 86 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	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	RS	2013-04-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB	RS	2013-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB		2013-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB		2013-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB		2013-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB		2013-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB		2013-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB		2013-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB		2013-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB		2013-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB		2013-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB		2013-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB		2013-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB		2013-04-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB		2013-04-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB		2013-04-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB		2013-04-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB		2013-04-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB		2013-04-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202644-001	NIFEDIPINE	10MG	CAPSULE / ORAL	AB		2013-04-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202644-002	NIFEDIPINE	20MG	CAPSULE / ORAL	AB		2013-04-25	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202644-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202644-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202644-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202644-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202644-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202644-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202644-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202644-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202644-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202644-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202644-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202644-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202644-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202644-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202644-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202644-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202644-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202644-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202644-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202644-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202644-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202644-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202644-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202644-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202644-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202644-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202644-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202644-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202644-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202644-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202644-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202644-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202644-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202644-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202644-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202644-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202644-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202644-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202644-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202644-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NIFEDIPINE	10 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
198032	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
bddfd658-ac61-4ba2-a3fa-07acc35d368a	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
70518-4625-0	Nifedipine	50 in 1 BOX	CAPSULE	50		1
70518-4625-1	Nifedipine	1 in 1 POUCH	CAPSULE	1		1

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	Major Pharmaceuticals	acb493a3-b8f2-41a9-8ab2-550d97c4592a	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202644 application number: ANDA202644
Nifedipine	NIFEDIPINE	REMEDYREPACK INC.	bddfd658-ac61-4ba2-a3fa-07acc35d368a	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202644 application number: ANDA202644 ndc (package): 70518-4625-0 ndc (product): 70518-4625 ndc11 (package): 70518462500
Nifedipine	NIFEDIPINE	Cardinal Health 107, LLC	472621b6-c2b7-4582-9ceb-7cead55ff247	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202644 application number: ANDA202644
Nifedipine	NIFEDIPINE	Chartwell RX, LLC	5014847e-389d-48c1-8350-b9b24ca8d2a4	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202644 application number: ANDA202644
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	51cdb22b-035f-47d7-8048-38006e2589f2	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202644 application number: ANDA202644
Nifedipine	NIFEDIPINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b8b8cfee-ea71-44c2-81af-675efecfdf15	2023-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202644 application number: ANDA202644

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
198032	NIFEdipine 10 MG Oral Capsule	PSN	bddfd658-ac61-4ba2-a3fa-07acc35d368a	1
198032	nifedipine 10 MG Oral Capsule	SCD	bddfd658-ac61-4ba2-a3fa-07acc35d368a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4625-0	70518462500	50 POUCH in 1 BOX (70518-4625-0) / 1 CAPSULE in 1 POUCH (70518-4625-1)	50 pouch	2026-04-24	No	No	Current