Nifedical

Product NDC: 63629-1559
11-digit product format: 636291559
Labeler code: 63629
Product ID: 63629-1559_4d0c14a7-3af6-45fc-bcd3-5e62b5566e46
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nifedipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA075289
Marketing category: ANDA
Marketing start: 2001-02-09
Marketing end: 0000-00-00
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: 2019-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-1559		D	Discontinued by firm	2026-08-07
excluded package	package	63629-1559	63629-1559-1	D	Discontinued by firm	2026-08-07
excluded package	package	63629-1559	63629-1559-2	D	Discontinued by firm	2026-08-07
excluded package	package	63629-1559	63629-1559-3	D	Discontinued by firm	2026-08-07
excluded package	package	63629-1559	63629-1559-4	D	Discontinued by firm	2026-08-07
excluded package	package	63629-1559	63629-1559-5	D	Discontinued by firm	2026-08-07

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 2 · 84 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	63629-1559-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1559-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1559-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1559-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1559-1	`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	63629-1559-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1559-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1559-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1559-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1559-1	`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	63629-1559-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1559-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1559-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1559-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1559-1	`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	63629-1559-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1559-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1559-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1559-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1559-1	`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	63629-1559-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1559-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1559-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1559-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1559-1	`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	63629-1559-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-1559-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-1559-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-1559-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-1559-1	`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	63629-1559-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-1559-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-1559-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-1559-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-1559-1	`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	63629-1559-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-1559-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-1559-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-1559-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-1559-1	`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	63629-1559-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-1559-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-1559-5	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-1559-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-1559-1	`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	63629-1559-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-1559-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-1559-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-1559-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-1559-1	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075289-001	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2000-09-27
A075289-002	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2001-02-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075289-001	AB2
A075289-002	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 3 · 82 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	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A075289-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075289-002	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075289-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075289-002	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075289-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075289-002	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075289-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075289-002	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075289-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075289-002	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075289-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075289-002	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075289-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075289-002	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075289-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075289-002	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075289-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075289-002	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075289-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075289-002	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075289-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075289-002	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075289-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075289-002	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075289-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075289-002	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075289-001	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075289-002	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075289-001	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075289-002	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075289-001	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075289-002	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075289-001	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075289-002	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075289-001	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075289-002	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075289-001	AB2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075289-002	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075289-001	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075289-002	AB2	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-1559-1	2021-04-21	Nifedipine Extended-Release Tablets, USP
63629-1559-2	2021-04-21	Nifedipine Extended-Release Tablets, USP
63629-1559-3	2021-04-21	Nifedipine Extended-Release Tablets, USP
63629-1559-4	2021-04-21	Nifedipine Extended-Release Tablets, USP
63629-1559-5	2021-04-21	Nifedipine Extended-Release Tablets, USP
63629-1559-1	2020-01-31	Nifedipine Extended-Release Tablets, USP
63629-1559-2	2020-01-31	Nifedipine Extended-Release Tablets, USP
63629-1559-3	2020-01-31	Nifedipine Extended-Release Tablets, USP
63629-1559-4	2020-01-31	Nifedipine Extended-Release Tablets, USP
63629-1559-5	2020-01-31	Nifedipine Extended-Release Tablets, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1559-1	EA - Each	63629-1559	91f66a3c-4f94-445c-9218-eeb59b67b3ba	1	2013-02-13
63629-1559-2	EA - Each	63629-1559	46ea21e3-1484-4e3d-bb3b-10cf6a550207	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NIFEDIPINE	ACTIVE INGREDIENT	I9ZF7L6G2L	NIFEDICAL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
NIFEDIPINE	ACTIVE MOIETY	I9ZF7L6G2L	NIFEDICAL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	NIFEDICAL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NIFEDICAL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	NIFEDICAL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NIFEDICAL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	NIFEDICAL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NIFEDICAL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NIFEDICAL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	NIFEDICAL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)	INACTIVE INGREDIENT	5KY68S2577	NIFEDICAL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NIFEDICAL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NIFEDICAL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NIFEDICAL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NIFEDICAL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIFEDICAL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nifedipine	NIFEDIPINE	Bryant Ranch Prepack	d7475c68-6310-4b9a-81c1-9209a9ade75f	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075289 application number: ANDA075289
nifedipine	NIFEDIPINE	Oceanside Pharmaceuticals	c7874606-c71e-424c-b881-38697988e0d0	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075289 application number: ANDA075289

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I9ZF7L6G2L	NIFEDIPINE	21829-25-4	NIFEDIPINE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nifedipine Extended-Release Tablets, USP	Bryant Ranch Prepack	2017-12-25	HUMAN PRESCRIPTION DRUG LABEL	1009