Nifedipine

Product NDC: 68788-8164
11-digit product format: 687888164
Labeler code: 68788
Product ID: 68788-8164_1b46439f-291e-4b0f-9a43-7506c8bbf9cb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nifedipine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA210614
Marketing category: ANDA
Marketing start: 2022-04-04
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS	Approval date
A210614-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12
A210614-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12
A210614-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2019-03-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210614-001	AB2
A210614-002	AB2
A210614-003	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 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2019-03-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2019-03-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	RS	2019-03-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210614-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210614-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210614-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2019-03-12	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A210614-001	AB2	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210614-002	AB2	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210614-003	AB2	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210614-001	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210614-002	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210614-003	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210614-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210614-002	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210614-003	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210614-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210614-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210614-003	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210614-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210614-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210614-003	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210614-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210614-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210614-003	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210614-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210614-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210614-003	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210614-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210614-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210614-003	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210614-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210614-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210614-003	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210614-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210614-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210614-003	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210614-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210614-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210614-003	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210614-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210614-002	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210614-003	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210614-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210614-002	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210614-003	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210614-001	AB2	1	`79d66fd596c7…`

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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
cda16a27-f029-40a6-a0e8-2bed0de71169	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
68788-8164-1	Nifedipine	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	4
68788-8164-3	Nifedipine	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	4
68788-8164-6	Nifedipine	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	4
68788-8164-9	Nifedipine	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8164-1	EA - Each	68788-8164	d8dafc56-fb09-47ea-81c9-1f615ae66cf2	1	2022-05-04
68788-8164-3	EA - Each	68788-8164	77f0f67c-e912-47e5-93a7-51dc94aa7ad4	1	2022-05-04
68788-8164-6	EA - Each	68788-8164	14dff9da-d2af-43c0-be3f-ba9b787ec47d	1	2022-05-04
68788-8164-9	EA - Each	68788-8164	1616c1d1-c134-4087-9867-696b0c8b314f	1	2022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8164	NIFEDIPINE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]	3	Current NDC, Legacy NDC, 4 package rows	20240724_cda16a27-f029-40a6-a0e8-2bed0de71169.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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	71a4e00b-8386-4da1-8515-a0e7e8db104d	2023-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210614 application number: ANDA210614

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
1812013	NIFEdipine 60 MG Osmotic 24HR Extended Release Oral Tablet	PSN	cda16a27-f029-40a6-a0e8-2bed0de71169	4
1812013	Osmotic 24 HR nifedipine 60 MG Extended Release Oral Tablet	SCD	cda16a27-f029-40a6-a0e8-2bed0de71169	4
1812013	nifedipine 60 MG Osmotic 24 HR Extended Release Oral Tablet	SY	cda16a27-f029-40a6-a0e8-2bed0de71169	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8164-1	68788816401	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8164-1)	2022-04-04	0000-00-00	No	No	Current
68788-8164-3	68788816403	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8164-3)	2022-04-04	0000-00-00	No	No	Current
68788-8164-6	68788816406	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8164-6)	2022-04-04	0000-00-00	No	No	Current
68788-8164-9	68788816409	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8164-9)	2022-04-04	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	Preferred Pharmaceuticals Inc.	2026-08-04	HUMAN PRESCRIPTION DRUG LABEL	5