Nifedipine

Product NDC: 71610-012
11-digit product format: 716100012
Labeler code: 71610
Product ID: 71610-012_15325d8c-d716-9819-e063-6294a90a06d9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nifedipine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA075269
Marketing category: ANDA
Marketing start: 2000-12-04
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: 2026-12-31
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
A075269-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-12-04
A075269-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-12-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075269-001	AB1
A075269-002	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 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	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075269-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075269-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2000-12-04	`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	A075269-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075269-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075269-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075269-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075269-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075269-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075269-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075269-002	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075269-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075269-002	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075269-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075269-002	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075269-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075269-002	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075269-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075269-002	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075269-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075269-002	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075269-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075269-002	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075269-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075269-002	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075269-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075269-002	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075269-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075269-002	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075269-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075269-002	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075269-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075269-002	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075269-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075269-002	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075269-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075269-002	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075269-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075269-002	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075269-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075269-002	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075269-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075269-002	AB1	1	`782e0a99824c…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198035	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
81e6c8e7-e826-4abb-ad58-1dee62091a66	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
71610-012-04	Nifedipine	4000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	4000	4
71610-012-16	Nifedipine	6000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	6000	4
71610-012-60	Nifedipine	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	4
71610-012-80	Nifedipine	180 in 1 BOTTLE	TABLET, EXTENDED RELEASE	180	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-012-04	EA - Each	71610-012	c4318f2c-7ff9-4ee0-973d-2e8e2bff7bd8	1	2024-05-16
71610-012-16	EA - Each	71610-012	1e3dbdcf-e9e1-4fd2-9100-e7d94efcb136	1	2021-11-09
71610-012-30	EA - Each	71610-012	62dda764-3350-4278-96f2-7b443a569fc3	1	2018-03-08
71610-012-60	EA - Each	71610-012	8076ec35-c8ee-4a96-a289-20bd09e28df2	1	2018-03-08
71610-012-80	EA - Each	71610-012	2e3ad28a-16e2-4668-8e6c-fd18acce4595	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-012	NIFEDIPINE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	4	Current NDC, Legacy NDC, 4 package rows	20240407_81e6c8e7-e826-4abb-ad58-1dee62091a66.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	59724871-b495-4911-a86d-20069ec42edd	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	cb9d013a-2303-4e1d-a539-8ff04d5ec91d	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	0b4e9bbc-4c16-4611-9ea2-903852804227	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269
Nifedipine	NIFEDIPINE	Oceanside Pharmaceuticals	fb6d8f32-198e-4ccf-bf25-069c03d624fd	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	d9dec600-4e11-8292-e053-2a95a90a6842	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269
Nifedipine	NIFEDIPINE	Oceanside Pharmaceuticals	cb051508-60f3-4b89-9da0-5261024bd7f4	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	81e6c8e7-e826-4abb-ad58-1dee62091a66	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269 ndc (product): 71610-012
Nifedipine	NIFEDIPINE	A-S Medication Solutions	af5a6330-1819-4724-9f08-da45ac9fb478	2023-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	95a53fc5-852d-4892-af20-2aaece9399ba	2018-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075269 application number: ANDA075269

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
198035	NIFEdipine 60 MG 24HR Extended Release Oral Tablet	PSN	81e6c8e7-e826-4abb-ad58-1dee62091a66	4
198035	24 HR nifedipine 60 MG Extended Release Oral Tablet	SCD	81e6c8e7-e826-4abb-ad58-1dee62091a66	4
198035	nifedipine 60 MG 24 HR Extended Release Oral Tablet	SY	81e6c8e7-e826-4abb-ad58-1dee62091a66	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-012-04	71610001204	4000 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-04)	2024-04-02		No	No	Current
71610-012-16	71610001216	6000 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-16)	2021-09-20	0000-00-00	No	No	Current
71610-012-30	71610001230	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-30)	2017-11-17	0000-00-00	No	No	Current
71610-012-60	71610001260	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-60)	2017-11-15	0000-00-00	No	No	Current
71610-012-80	71610001280	180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-80)	2019-05-01		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nifedipine Extended-Release Tablets, USP 60 mg	Aphena Pharma Solutions - Tennessee, LLC	2024-04-03	HUMAN PRESCRIPTION DRUG LABEL	4