Nifedipine

Product NDC: 68682-107
11-digit product format: 686820107
Labeler code: 68682
Product ID: 68682-107_8e94acd8-b4bb-4b2f-be6f-9783fd5e1d04
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nifedipine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Oceanside Pharmaceuticals
Application: ANDA076070
Marketing category: ANDA
Marketing start: 2002-08-16
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 43.

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 · 43 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	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076070-001	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2002-08-16	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A076070-001	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076070-001	AB1	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

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
198036	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
ca5b0178-4e5f-4077-ada5-7058b0a03858	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68682-107-10	Nifedipine	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68682-107-10	EA - Each	68682-107	512979e0-1832-47fd-ad1c-d10ec3e9cf77	1	2016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68682-107	NIFEDIPINE TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	6	Current NDC, Legacy NDC, 1 package rows	20200114_ca5b0178-4e5f-4077-ada5-7058b0a03858.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 ndc (product): 68682-107
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
198036	NIFEdipine 90 MG 24HR Extended Release Oral Tablet	PSN	888b3fac-2f2f-42b8-92d1-d37b6ed225a5	101
198036	24 HR nifedipine 90 MG Extended Release Oral Tablet	SCD	888b3fac-2f2f-42b8-92d1-d37b6ed225a5	101
198036	nifedipine 90 MG 24 HR Extended Release Oral Tablet	SY	888b3fac-2f2f-42b8-92d1-d37b6ed225a5	101
198036	NIFEdipine 90 MG 24HR Extended Release Oral Tablet	PSN	ca5b0178-4e5f-4077-ada5-7058b0a03858	7
198036	24 HR nifedipine 90 MG Extended Release Oral Tablet	SCD	ca5b0178-4e5f-4077-ada5-7058b0a03858	7
198036	nifedipine 90 MG 24 HR Extended Release Oral Tablet	SY	ca5b0178-4e5f-4077-ada5-7058b0a03858	7
198036	NIFEdipine 90 MG 24HR Extended Release Oral Tablet	PSN	36b07283-fc0e-4a14-b78f-1d2ab80e7f31	1
198036	24 HR nifedipine 90 MG Extended Release Oral Tablet	SCD	36b07283-fc0e-4a14-b78f-1d2ab80e7f31	1
198036	nifedipine 90 MG 24 HR Extended Release Oral Tablet	SY	36b07283-fc0e-4a14-b78f-1d2ab80e7f31	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68682-107-10	68682010710	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-107-10)	2002-08-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nifedipine Extended-Release Tablets, USP 90 mg	Bryant Ranch Prepack	2026-03-19	HUMAN PRESCRIPTION DRUG LABEL	101
Nifedipine Extended-Release Tablets, USP 90 mg	Oceanside Pharmaceuticals \| Bausch Health Companies Inc.	2026-02-05	HUMAN PRESCRIPTION DRUG LABEL	7
Nifedipine Extended-Release Tablets, USP 90 mg	Aphena Pharma Solutions - Tennessee, LLC	2018-05-07	HUMAN PRESCRIPTION DRUG LABEL	1
Nifedipine Extended-Release Tablets, USP 90 mg	NuCare Pharmaceuticals, Inc. \| NuCarePharmaceuticals, Inc.	2017-07-10	HUMAN PRESCRIPTION DRUG LABEL	1