Nifedipine

Product NDC: 68382-686
Requested package NDC: 68382-686-95
11-digit product format: 683820686
Labeler code: 68382
Product ID: 68382-686_c0025ef1-99d7-4b31-9d99-4be010b2b9fb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nifedipine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Zydus Pharmaceuticals (USA) Inc.
Application: ANDA210012
Marketing category: ANDA
Marketing start: 2018-02-02
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: 2026-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A210012-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19
A210012-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19
A210012-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A210012-001	AB2
A210012-002	AB2
A210012-003	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 4 · 129 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	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210012-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210012-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210012-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2017-12-19	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A210012-001	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210012-002	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210012-003	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210012-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210012-002	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210012-003	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210012-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210012-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210012-003	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210012-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210012-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210012-003	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210012-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210012-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210012-003	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210012-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210012-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210012-003	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210012-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210012-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210012-003	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210012-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210012-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210012-003	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210012-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210012-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210012-003	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210012-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210012-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210012-003	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210012-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210012-002	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210012-003	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210012-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210012-002	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210012-003	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210012-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210012-002	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210012-003	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210012-001	AB2	1	`301d65b070ca…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NIFEDIPINE	60 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1812011	Internal RxNorm lookup
1812013	Internal RxNorm lookup
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
657221d5-9eb8-42f9-8cdc-39cefc386f51	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	SPL version
68382-686-01	Nifedipine	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	5
68382-686-10	Nifedipine	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	5
68382-686-95	Nifedipine	300 in 1 BOTTLE	TABLET, EXTENDED RELEASE	300	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-686	NIFEDIPINE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	5	Current NDC, Legacy NDC, 3 package rows	20241212_657221d5-9eb8-42f9-8cdc-39cefc386f51.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	Zydus Lifesciences Limited	ac3f68b2-29b5-45c1-b6a2-54704dc3143e	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210012 application number: ANDA210012
Nifedipine	NIFEDIPINE	Zydus Pharmaceuticals (USA) Inc.	657221d5-9eb8-42f9-8cdc-39cefc386f51	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210012 application number: ANDA210012 ndc (package): 68382-686-95 ndc (product): 68382-686 ndc11 (package): 68382068695

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	657221d5-9eb8-42f9-8cdc-39cefc386f51	5
1812013	NIFEdipine 60 MG Osmotic 24HR Extended Release Oral Tablet	PSN	657221d5-9eb8-42f9-8cdc-39cefc386f51	5
1812015	NIFEdipine 90 MG Osmotic 24HR Extended Release Oral Tablet	PSN	657221d5-9eb8-42f9-8cdc-39cefc386f51	5
1812011	Osmotic 24 HR nifedipine 30 MG Extended Release Oral Tablet	SCD	657221d5-9eb8-42f9-8cdc-39cefc386f51	5
1812013	Osmotic 24 HR nifedipine 60 MG Extended Release Oral Tablet	SCD	657221d5-9eb8-42f9-8cdc-39cefc386f51	5
1812015	Osmotic 24 HR nifedipine 90 MG Extended Release Oral Tablet	SCD	657221d5-9eb8-42f9-8cdc-39cefc386f51	5
1812011	nifedipine 30 MG Osmotic 24 HR Extended Release Oral Tablet	SY	657221d5-9eb8-42f9-8cdc-39cefc386f51	5
1812013	nifedipine 60 MG Osmotic 24 HR Extended Release Oral Tablet	SY	657221d5-9eb8-42f9-8cdc-39cefc386f51	5
1812015	nifedipine 90 MG Osmotic 24 HR Extended Release Oral Tablet	SY	657221d5-9eb8-42f9-8cdc-39cefc386f51	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-686-95	68382068695	300 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-686-95)	2018-02-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NIFEdipine Extended-Release Tablets For Oral Use	Zydus Pharmaceuticals (USA) Inc. \| Zydus Lifesciences Limited	2024-12-11	HUMAN PRESCRIPTION DRUG LABEL	5