nifedipine

Product NDC: 68682-108
11-digit product format: 686820108
Labeler code: 68682
Product ID: 68682-108_68cca98c-658a-48b4-9630-478b62b1471e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nifedipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Oceanside Pharmaceuticals
Application: ANDA075289
Marketing category: ANDA
Marketing start: 2000-09-27
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: 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 · 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NIFEDIPINE	30 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1812011	Internal RxNorm lookup
1812013	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
c7874606-c71e-424c-b881-38697988e0d0	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
68682-108-10	nifedipine	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100		7
68682-108-30	nifedipine	300 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	300		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68682-108-10	EA - Each	68682-108	bfb24e9f-cf69-4564-9421-a05191802b7d	1	2017-03-06
68682-108-30	EA - Each	68682-108	219a916f-efb3-424d-b8d6-582b3cb35a6b	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68682-108	NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]	6	Current NDC, Legacy NDC, 2 package rows	20200114_c7874606-c71e-424c-b881-38697988e0d0.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 ndc (product): 68682-108

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
1812011	NIFEdipine 30 MG Osmotic 24HR Extended Release Oral Tablet	PSN	c7874606-c71e-424c-b881-38697988e0d0	7
1812013	NIFEdipine 60 MG Osmotic 24HR Extended Release Oral Tablet	PSN	c7874606-c71e-424c-b881-38697988e0d0	7
1812011	Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet	SCD	c7874606-c71e-424c-b881-38697988e0d0	7
1812013	Osmotic 24 HR nifedipine 60 MG Extended Release Oral Tablet	SCD	c7874606-c71e-424c-b881-38697988e0d0	7
1812011	nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet	SY	c7874606-c71e-424c-b881-38697988e0d0	7
1812013	nifedipine 60 MG Osmotic 24 HR Extended Release Oral Tablet	SY	c7874606-c71e-424c-b881-38697988e0d0	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68682-108-10	68682010810	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-108-10)	2000-09-27	0000-00-00	No	No	Current
68682-108-30	68682010830	300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-108-30)	2000-09-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nifedipine Extended-Release Tablets, USP 30 mg and 60 mg For Oral Use	Oceanside Pharmaceuticals \| Bausch Health Companies, Inc.	2026-02-09	HUMAN PRESCRIPTION DRUG LABEL	7
Nifedipine Extended-Release Tablets, USP Rx only For Oral Use	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL	2
Nifedipine Extended-Release Tablets, USP Rx only For Oral Use	REMEDYREPACK INC.	2019-11-03	HUMAN PRESCRIPTION DRUG LABEL	3