NifedicalXL

Product NDC: 53217-010
11-digit product format: 532170010
Labeler code: 53217
Product ID: 53217-010_c8bbdb77-8cb5-437b-96b7-a064ba98c84d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nifedipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA075289
Marketing category: ANDA
Marketing start: 2000-12-11
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: 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53217-010		I	Inactivated by FDA	2026-09-14
excluded package	package	53217-010	53217-010-30	I	Inactivated by FDA	2026-09-14
excluded package	package	53217-010	53217-010-60	I	Inactivated by FDA	2026-09-14
excluded package	package	53217-010	53217-010-90	I	Inactivated by FDA	2026-09-14

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	53217-010-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-010-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53217-010-60	`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	53217-010-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-010-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53217-010-60	`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	53217-010-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-010-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53217-010-60	`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	53217-010-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-010-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53217-010-60	`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	53217-010-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-010-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53217-010-60	`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	53217-010-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-010-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53217-010-60	`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	53217-010-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-010-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53217-010-60	`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	53217-010-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-010-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53217-010-60	`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	53217-010-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53217-010-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53217-010-60	`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	53217-010-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53217-010-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53217-010-60	`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	53217-010-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53217-010-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53217-010-60	`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	53217-010-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53217-010-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53217-010-60	`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	53217-010-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53217-010-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53217-010-60	`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	53217-010-90	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53217-010-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53217-010-60	`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	53217-010-90	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53217-010-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53217-010-60	`1332a3947898…`	`d4bfe170f9cd…`

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
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 · 86 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
2026-09-14 22:38:34	2026-08	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075289-001	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2000-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075289-002	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2001-02-06	`caaa826d4ba7…`
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…`

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	A075289-001	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075289-002	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075289-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075289-002	AB2	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

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
53217-010-30	2020-01-31	C162847	48780-1	9d75b9d0-a2cd-f424-e053-dadaa90a57ce	Nifedical XL ® (NIFEDIPINE) Tablet, Film Coated Extended Release USP
53217-010-60	2020-01-31	C162847	48780-1	9d75b9d0-a2cd-f424-e053-dadaa90a57ce	Nifedical XL ® (NIFEDIPINE) Tablet, Film Coated Extended Release USP
53217-010-90	2020-01-31	C162847	48780-1	9d75b9d0-a2cd-f424-e053-dadaa90a57ce	Nifedical XL ® (NIFEDIPINE) Tablet, Film Coated Extended Release USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53217-010-30	NifedicalXLXL	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	30	1
53217-010-60	NifedicalXLXL	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	60	1
53217-010-90	NifedicalXLXL	90 in 1 BOTTLE, PLASTIC	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
53217-010-30	EA - Each	53217-010	b3000817-215e-4f94-887a-75fe515c1b7c	1	2015-10-02
53217-010-60	EA - Each	53217-010	7225c896-3c58-4faf-843a-14b1aad6855f	1	2015-10-02
53217-010-90	EA - Each	53217-010	ec6ccd4a-0fd2-4611-b6f6-7979d45fe296	1	2015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-010	NIFEDICALXL XL (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 3 package rows	20140214_2b62f40a-610e-4f37-8798-eaa7bf9377cd.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
351438	Nifedical XL 60 MG 24HR Extended Release Oral Tablet	PSN	2b62f40a-610e-4f37-8798-eaa7bf9377cd	1
1812013	NIFEdipine 60 MG Osmotic 24HR Extended Release Oral Tablet	PSN	2b62f40a-610e-4f37-8798-eaa7bf9377cd	1
351438	Osmotic 24 HR nifedipine 60 MG Extended Release Oral Tablet [Nifedical]	SBD	2b62f40a-610e-4f37-8798-eaa7bf9377cd	1
1812013	Osmotic 24 HR nifedipine 60 MG Extended Release Oral Tablet	SCD	2b62f40a-610e-4f37-8798-eaa7bf9377cd	1
351438	Nifedical 60 MG Osmotic 24 HR Extended Release Oral Tablet	SY	2b62f40a-610e-4f37-8798-eaa7bf9377cd	1
1812013	nifedipine 60 MG Osmotic 24 HR Extended Release Oral Tablet	SY	2b62f40a-610e-4f37-8798-eaa7bf9377cd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-010-30	53217001030	30 in 1 BOTTLE, PLASTIC	Historical
53217-010-60	53217001060	60 in 1 BOTTLE, PLASTIC	Historical
53217-010-90	53217001090	90 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nifedical XL ® (NIFEDIPINE) Tablet, Film Coated Extended Release USP	Aidarex Pharmaceuticals LLC	2013-10-02	HUMAN PRESCRIPTION DRUG LABEL	1