Nifedipine

Product NDC: 63187-875
11-digit product format: 631870875
Labeler code: 63187
Product ID: 63187-875_19b531f9-27f9-42e5-8c1e-7015c256bb22
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nifedipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA077127
Marketing category: ANDA
Marketing start: 2005-11-21
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: 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
A077127-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21
A077127-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21
A077127-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077127-001	AB2
A077127-002	AB2
A077127-003	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	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077127-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077127-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2007-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077127-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2005-11-21	`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	A077127-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077127-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077127-003	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077127-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077127-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077127-003	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077127-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077127-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077127-003	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077127-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077127-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077127-003	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077127-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077127-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077127-003	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077127-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077127-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077127-003	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077127-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077127-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077127-003	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077127-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077127-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077127-003	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077127-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077127-002	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077127-003	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077127-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077127-002	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077127-003	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077127-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077127-002	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077127-003	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077127-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077127-002	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077127-003	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077127-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077127-002	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077127-003	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077127-001	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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1812011	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
4b6418a8-600f-470e-adf1-56207bb25c38	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
63187-875-30	Nifedipine	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	3
63187-875-60	Nifedipine	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	3
63187-875-90	Nifedipine	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-875-90	EA - Each	63187-875	3ce541fb-ea1a-49be-a534-7c0559866840	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-875	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 3 package rows	20191113_4b6418a8-600f-470e-adf1-56207bb25c38.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine ER	NIFEDIPINE	AvPAK	d1a78ff2-7672-3e69-00ef-63d203c80484	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077127 application number: ANDA077127
Nifedipine	NIFEDIPINE	Chartwell RX, LLC	0a8e3090-7733-4914-bacb-01bbdc8deb30	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077127 application number: ANDA077127
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	86c1bdae-c749-4ec3-90f6-7ebe8e76c461	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077127 application number: ANDA077127
Nifedipine	NIFEDIPINE	Cardinal Health 107, LLC	593d8ca3-c303-4512-96a6-d4860e02cd83	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077127 application number: ANDA077127
Nifedipine	NIFEDIPINE	American Health Packaging	b11026f8-dea0-49ac-8725-0ef7dc27923f	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077127 application number: ANDA077127
Nifedipine	NIFEDIPINE	PD-Rx Pharmaceuticals, Inc.	75003769-7800-4bc7-b709-35b4caec2c2f	2025-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077127 application number: ANDA077127
Nifedipine	NIFEDIPINE	Lannett Company, Inc.	331db003-cc8e-4509-9415-20e48c5cc5b2	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077127 application number: ANDA077127
Nifedipine	NIFEDIPINE	A-S Medication Solutions	ec13ec71-626f-4664-b264-f67ba72071ae	2023-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077127 application number: ANDA077127
Nifedipine	NIFEDIPINE	Proficient Rx LP	4b6418a8-600f-470e-adf1-56207bb25c38	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077127 application number: ANDA077127 ndc (product): 63187-875

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	4b6418a8-600f-470e-adf1-56207bb25c38	3
1812011	Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet	SCD	4b6418a8-600f-470e-adf1-56207bb25c38	3
1812011	nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet	SY	4b6418a8-600f-470e-adf1-56207bb25c38	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-875-30	63187087530	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-875-30)	2017-07-03	0000-00-00	No	No	Current
63187-875-60	63187087560	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-875-60)	2017-07-03	0000-00-00	No	No	Current
63187-875-90	63187087590	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-875-90)	2017-07-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nifedipine Extended-release Tablets, USP	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3