nifedipine

Product NDC: 70807-503
11-digit product format: 708070503
Labeler code: 70807
Product ID: 70807-503_3816123b-e06c-4abf-aead-2bed62b89c15
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nifedipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Elite Pharmaceutical Solution, Inc.
Application: ANDA212016
Marketing category: ANDA
Marketing start: 2021-10-15
Substance: NIFEDIPINE
Active strength: 90 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212016-001	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2020-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212016-001	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.

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	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212016-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2020-11-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212016-001	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212016-001	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212016-001	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212016-001	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212016-001	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212016-001	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212016-001	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212016-001	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212016-001	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212016-001	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212016-001	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212016-001	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212016-001	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212016-001	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212016-001	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212016-001	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212016-001	AB2	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212016-001	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212016-001	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212016-001	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212016-001	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212016-001	AB2	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212016-001	AB2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212016-001	AB2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212016-001	AB2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212016-001	AB2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212016-001	AB2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212016-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212016-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212016-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212016-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212016-001	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212016-001	AB2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212016-001	AB2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212016-001	AB2	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212016-001	AB2	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: nifedipine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NIFEDIPINE	90 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
I9ZF7L6G2L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1812015	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1df07edb-630d-4c70-a68c-bdbc607ce850	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
bbd94e90-e531-9113-45c1-29860f331640	Product name	7	20230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffd	Product name	4	20220126
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
308fd2ea-d88a-e021-96c1-7c2ab74d6e4b	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70807-503-12	nifedipine	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100		3
70807-503-13	nifedipine	300 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	300		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70807-503	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [ELITE PHARMACEUTICAL SOLUTION, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20240111_1df07edb-630d-4c70-a68c-bdbc607ce850.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nifedipine	NIFEDIPINE	Elite Pharmaceutical Solution, Inc.	1df07edb-630d-4c70-a68c-bdbc607ce850	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212016 application number: ANDA212016 ndc (product): 70807-503

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
1812015	NIFEdipine 90 MG Osmotic 24HR Extended Release Oral Tablet	PSN	1df07edb-630d-4c70-a68c-bdbc607ce850	3
1812015	Osmotic 24 HR nifedipine 90 MG Extended Release Oral Tablet	SCD	1df07edb-630d-4c70-a68c-bdbc607ce850	3
1812015	nifedipine 90 MG Osmotic 24 HR Extended Release Oral Tablet	SY	1df07edb-630d-4c70-a68c-bdbc607ce850	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70807-503-12	70807050312	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70807-503-12)	2021-10-15	0000-00-00	No	No	Current
70807-503-13	70807050313	300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70807-503-13)	2021-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nifedipine Extended-Release Tablets, USP For Oral Use	Elite Pharmaceutical Solution, Inc. \| Patheon Pharmaceuticals Inc.	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	3