Nifedipine

Product NDC: 42254-095
11-digit product format: 422540095
Labeler code: 42254
Product ID: 42254-095_4bb9f3b7-2cc0-487d-9afa-027ddf7d7c16
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nifedipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA077127
Marketing category: ANDA
Marketing start: 2005-11-21
Marketing end: 0000-00-00
Substance: NIFEDIPINE
Active strength: 60 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42254-095		I	Inactivated by FDA		2026-08-03
excluded package	package	42254-095	42254-095-90	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42254-095-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42254-095-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42254-095-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42254-095-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42254-095-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42254-095-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42254-095-90	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42254-095-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42254-095-90	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42254-095-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42254-095-90	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42254-095-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42254-095-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42254-095-90	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42254-095-90	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42254-095-90	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42254-095-90	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42254-095-90	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42254-095-90	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42254-095-90	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42254-095-90	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42254-095-90	`110d247fa046…`	`a55b01930146…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42254-095-90	2019-09-24	C162847	48780-1	9350213a-3d31-c013-e053-90daa90a1393	Nifedipine Extended-release Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42254-095-90	Nifedipine	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-095-90	EA - Each	42254-095	2ab8f417-ec7b-4762-96dc-f8e901878779	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NIFEDIPINE	ACTIVE INGREDIENT	I9ZF7L6G2L	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
NIFEDIPINE	ACTIVE MOIETY	I9ZF7L6G2L	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
CELLULOSE ACETATE	INACTIVE INGREDIENT	3J2P07GVB6	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-095	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20120411_4bb9f3b7-2cc0-487d-9afa-027ddf7d7c16.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

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
1812013	NIFEdipine 60 MG Osmotic 24HR Extended Release Oral Tablet	PSN	4bb9f3b7-2cc0-487d-9afa-027ddf7d7c16	1
1812013	Osmotic 24 HR nifedipine 60 MG Extended Release Oral Tablet	SCD	4bb9f3b7-2cc0-487d-9afa-027ddf7d7c16	1
1812013	nifedipine 60 MG Osmotic 24 HR Extended Release Oral Tablet	SY	4bb9f3b7-2cc0-487d-9afa-027ddf7d7c16	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42254-095-90	42254009590	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nifedipine Extended-release Tablets, USP	Rebel Distributors Corp	2011-12-27	HUMAN PRESCRIPTION DRUG LABEL	1