NIFEDIPINE

Product NDC: 68382-690
11-digit product format: 683820690
Labeler code: 68382
Product ID: 68382-690_18f1ad21-11a1-4d2d-b5bc-a88ac8c02f45
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NIFEDIPINE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Zydus Pharmaceuticals (USA) Inc.
Application: ANDA210184
Marketing category: ANDA
Marketing start: 2018-08-18
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: 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
A210184-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29
A210184-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29
A210184-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210184-001	AB1
A210184-002	AB1
A210184-003	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 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	A210184-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210184-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210184-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210184-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210184-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210184-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210184-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210184-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210184-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210184-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210184-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210184-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210184-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210184-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210184-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210184-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210184-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210184-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210184-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210184-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210184-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210184-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210184-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210184-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210184-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210184-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210184-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210184-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210184-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210184-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210184-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210184-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210184-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210184-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210184-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210184-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210184-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210184-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210184-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210184-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-06-29	`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	A210184-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210184-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210184-003	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210184-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210184-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210184-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210184-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210184-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210184-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210184-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210184-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210184-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210184-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210184-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210184-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210184-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210184-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210184-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210184-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210184-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210184-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210184-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210184-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210184-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210184-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210184-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210184-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210184-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210184-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210184-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210184-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210184-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210184-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210184-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210184-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210184-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210184-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210184-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210184-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210184-001	AB1	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	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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198034	Internal RxNorm lookup
198035	Internal RxNorm lookup
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
1c857df2-9cce-40de-95c3-b1274ed1e1bc	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
68382-690-01	NIFEDIPINE	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	4
68382-690-10	NIFEDIPINE	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	4
68382-690-16	NIFEDIPINE	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	4
68382-690-77	NIFEDIPINE	10 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	10	4
68382-690-77	NIFEDIPINE	10 in 1 CARTON	TABLET, EXTENDED RELEASE	10	4
68382-690-95	NIFEDIPINE	300 in 1 BOTTLE	TABLET, EXTENDED RELEASE	300	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-690	NIFEDIPINE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	4	Current NDC, Legacy NDC, 6 package rows	20240118_1c857df2-9cce-40de-95c3-b1274ed1e1bc.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	925e2ea9-f51a-4b89-ab5d-ce590b6c4d85	2024-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210184 application number: ANDA210184
NIFEDIPINE	NIFEDIPINE	Zydus Pharmaceuticals (USA) Inc.	1c857df2-9cce-40de-95c3-b1274ed1e1bc	2024-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210184 application number: ANDA210184 ndc (product): 68382-690

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
198034	NIFEdipine 30 MG 24HR Extended Release Oral Tablet	PSN	1c857df2-9cce-40de-95c3-b1274ed1e1bc	4
198035	NIFEdipine 60 MG 24HR Extended Release Oral Tablet	PSN	1c857df2-9cce-40de-95c3-b1274ed1e1bc	4
198036	NIFEdipine 90 MG 24HR Extended Release Oral Tablet	PSN	1c857df2-9cce-40de-95c3-b1274ed1e1bc	4
198034	24 HR nifedipine 30 MG Extended Release Oral Tablet	SCD	1c857df2-9cce-40de-95c3-b1274ed1e1bc	4
198035	24 HR nifedipine 60 MG Extended Release Oral Tablet	SCD	1c857df2-9cce-40de-95c3-b1274ed1e1bc	4
198036	24 HR nifedipine 90 MG Extended Release Oral Tablet	SCD	1c857df2-9cce-40de-95c3-b1274ed1e1bc	4
198034	nifedipine 30 MG 24 HR Extended Release Oral Tablet	SY	1c857df2-9cce-40de-95c3-b1274ed1e1bc	4
198035	nifedipine 60 MG 24 HR Extended Release Oral Tablet	SY	1c857df2-9cce-40de-95c3-b1274ed1e1bc	4
198036	nifedipine 90 MG 24 HR Extended Release Oral Tablet	SY	1c857df2-9cce-40de-95c3-b1274ed1e1bc	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-690-01	68382069001	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-690-01)		2018-08-18	0000-00-00	No	No	Current
68382-690-10	68382069010	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-690-10)		2018-08-18	0000-00-00	No	No	Current
68382-690-16	68382069016	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-690-16)		2018-08-18	0000-00-00	No	No	Current
68382-690-77	68382069077	10 BLISTER PACK in 1 CARTON (68382-690-77) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	10 blister pack	2018-08-18	0000-00-00	No	No	Current
68382-690-95	68382069095	300 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-690-95)		2018-08-18	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 RX Only	Zydus Pharmaceuticals (USA) Inc. \| Zydus Lifesciences Limited	2024-01-16	HUMAN PRESCRIPTION DRUG LABEL	4