Nifedipine

Product NDC: 68071-4097
Requested package NDC: 68071-4097-3
11-digit product format: 680714097
Labeler code: 68071
Product ID: 68071-4097_1d8e3521-5b68-3418-e063-6294a90a9c41
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nifedipine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA203126
Marketing category: ANDA
Marketing start: 2014-11-01
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A203126-001	NIFEDIPINE	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03
A203126-002	NIFEDIPINE	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03
A203126-003	NIFEDIPINE	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203126-001	AB2
A203126-002	AB2
A203126-003	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 · 123 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	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203126-002	NIFEDIPINE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203126-003	NIFEDIPINE	90MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203126-001	NIFEDIPINE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2014-04-03	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A203126-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203126-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203126-003	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203126-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203126-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203126-003	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203126-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203126-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203126-003	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203126-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203126-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203126-003	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203126-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203126-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203126-003	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203126-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203126-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203126-003	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203126-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203126-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203126-003	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203126-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203126-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203126-003	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203126-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203126-002	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203126-003	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203126-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203126-002	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203126-003	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203126-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203126-002	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203126-003	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203126-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203126-002	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203126-003	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203126-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203126-002	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203126-003	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203126-001	AB2	1	`8072bd15b7f6…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
5927fcff-9d1a-8322-e053-2991aa0ad289	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
bbd94e90-e531-9113-45c1-29860f331640	Product name	7	20230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffd	Product name	4	20220126
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
308fd2ea-d88a-e021-96c1-7c2ab74d6e4b	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-07-18	NIFEdipine Extended-release Tablets, USP
2023-01-30	NIFEdipine Extended-release Tablets, USP
2021-02-12	NIFEdipine Extended-release Tablets, USP
2021-01-29	NIFEdipine Extended-release Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4097-3	Nifedipine	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4097	NIFEDIPINE TABLET, EXTENDED RELEASE [NUCARE PHARMACEUTICALS,INC.]	5	Current NDC, Legacy NDC, 1 package rows	20240720_5927fcff-9d1a-8322-e053-2991aa0ad289.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nifedipine	NIFEDIPINE	Major Pharmaceuticals	b885b6b5-71c6-4799-8b23-5ee8c17938a0	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	Upsher-Smith Laboratories, LLC	160271a8-7922-2107-e054-00144ff88e88	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	Upsher-Smith Laboratories, LLC	3bf4282f-b063-4d35-8ef0-6f48b98e9deb	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	da565525-c77a-0571-e053-2995a90aaa11	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	Northwind Health Company, LLC	e3b04484-f330-9523-e053-2995a90a0e45	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	Golden State Medical Supply, Inc.	a84be46e-bb0c-d59f-e053-2a95a90aabde	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	NuCare Pharmaceuticals,Inc.	5927fcff-9d1a-8322-e053-2991aa0ad289	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126 ndc (package): 68071-4097-3 ndc (product): 68071-4097 ndc11 (package): 68071409703
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	6a68f67f-5b68-4f83-aad8-fc3177f5a0a4	2023-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	Bryant Ranch Prepack	4c4f8a8e-3995-4d2e-85d4-b6a45f5fac3e	2023-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	Proficient Rx LP	d428aa4d-4cc0-4b1e-b9f6-40ae65a735d6	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	Proficient Rx LP	838d6e8f-37b0-48d3-b701-c4fa32a87b85	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126
Nifedipine	NIFEDIPINE	Aphena Pharma Solutions - Tennessee, LLC	09a04e5f-d3b0-4ee3-b12d-f74203262179	2019-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203126 application number: ANDA203126

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
1812015	NIFEdipine 90 MG Osmotic 24HR Extended Release Oral Tablet	PSN	5927fcff-9d1a-8322-e053-2991aa0ad289	5
1812015	Osmotic 24 HR nifedipine 90 MG Extended Release Oral Tablet	SCD	5927fcff-9d1a-8322-e053-2991aa0ad289	5
1812015	nifedipine 90 MG Osmotic 24 HR Extended Release Oral Tablet	SY	5927fcff-9d1a-8322-e053-2991aa0ad289	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4097-3	68071409703	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-4097-3)	2017-09-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NIFEdipine Extended-release Tablets, USP	NuCare Pharmaceuticals,Inc.	2024-07-18	HUMAN PRESCRIPTION DRUG LABEL	5