Nifediac CC

Product NDC: 53808-0500
11-digit product format: 538080500
Labeler code: 53808
Product ID: 53808-0500_eaac3a82-2f22-47b4-b3a2-41aab8d9c4af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nifedipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA076070
Marketing category: ANDA
Marketing start: 2009-07-01
Marketing end: 0000-00-00
Substance: NIFEDIPINE
Active strength: 90 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	53808-0500		I	Inactivated by FDA		2026-08-07
excluded package	package	53808-0500	53808-0500-1	I	Inactivated by FDA		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 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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`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	53808-0500-1	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076070-001	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2002-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076070-001	AB1

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 2 · 41 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	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A076070-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076070-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076070-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076070-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076070-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076070-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076070-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076070-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076070-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076070-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076070-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076070-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076070-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076070-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076070-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076070-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076070-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076070-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076070-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076070-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076070-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076070-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076070-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076070-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076070-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076070-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076070-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076070-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076070-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076070-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076070-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076070-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076070-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076070-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076070-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076070-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076070-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076070-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076070-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076070-001	AB1	1	`cb3db0bc1861…`

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
53808-0500-1	2019-10-21	C162847	48780-1	956f9ecf-cb1f-621f-e053-dbdaa90a74ad	NIFEDIAC CC ® (nifedipine) Extended-release Tablets USP 90 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0500-1	Nifediac CC	30 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NIFEDIPINE	ACTIVE INGREDIENT	I9ZF7L6G2L	NIFEDIAC CC (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
NIFEDIPINE	ACTIVE MOIETY	I9ZF7L6G2L	NIFEDIAC CC (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	NIFEDIAC CC (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NIFEDIAC CC (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NIFEDIAC CC (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ETHYLCELLULOSE	INACTIVE INGREDIENT	7Z8S9VYZ4B	NIFEDIAC CC (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	NIFEDIAC CC (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	NIFEDIAC CC (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NIFEDIAC CC (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	NIFEDIAC CC (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	NIFEDIAC CC (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NIFEDIAC CC (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NIFEDIAC CC (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	NIFEDIAC CC (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0500	NIFEDIAC CC (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20100811_fa952140-c9f6-472d-a04f-96c44fe9bca8.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	888b3fac-2f2f-42b8-92d1-d37b6ed225a5	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076070 application number: ANDA076070
Nifedipine	NIFEDIPINE	Oceanside Pharmaceuticals	ca5b0178-4e5f-4077-ada5-7058b0a03858	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076070 application number: ANDA076070
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	36b07283-fc0e-4a14-b78f-1d2ab80e7f31	2018-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076070 application number: ANDA076070

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
880437	Nifediac CC 90 MG 24HR Extended Release Oral Tablet	PSN	fa952140-c9f6-472d-a04f-96c44fe9bca8	1
198036	NIFEdipine 90 MG 24HR Extended Release Oral Tablet	PSN	fa952140-c9f6-472d-a04f-96c44fe9bca8	1
880437	24 HR nifedipine 90 MG Extended Release Oral Tablet [Nifediac]	SBD	fa952140-c9f6-472d-a04f-96c44fe9bca8	1
198036	24 HR nifedipine 90 MG Extended Release Oral Tablet	SCD	fa952140-c9f6-472d-a04f-96c44fe9bca8	1
880437	24 HR Nifediac CC 90 MG Extended Release Oral Tablet	SY	fa952140-c9f6-472d-a04f-96c44fe9bca8	1
880437	Nifediac CC 90 MG 24 HR Extended Release Oral Tablet	SY	fa952140-c9f6-472d-a04f-96c44fe9bca8	1
198036	nifedipine 90 MG 24 HR Extended Release Oral Tablet	SY	fa952140-c9f6-472d-a04f-96c44fe9bca8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0500-1	53808050001	30 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NIFEDIAC CC ® (nifedipine) Extended-release Tablets USP 90 mg	State of Florida DOH Central Pharmacy	2010-06-07	HUMAN PRESCRIPTION DRUG LABEL	1