Home NDC 62112-8045-2 Nifedipine
Product NDC 62112-8045
Requested package NDC 62112-8045-2
11-digit product format 621128045
Labeler code 62112
Product ID 62112-8045_902e6043-5b3d-9a4b-e053-2a95a90a3d66
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nifedipine
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Intergel Pharmaceuticals Inc
Application ANDA072781
Marketing category ANDA
Marketing start 2009-08-01
Marketing end 0000-00-00
Substance NIFEDIPINE
Active strength 10 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 19 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 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…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…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 8dfbde2a14a4…c9ff85d89658…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A072781-001 NIFEDIPINE NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072781-001 AB
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 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62112-8045-2 Nifedipine 100 in 1 BOTTLE CAPSULE, LIQUID FILLED 100 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62112-8045 NIFEDIPINE CAPSULE, LIQUID FILLED [INTERGEL PHARMACEUTICALS INC] 7 Legacy NDC, 1 package rows 20190816_a3daa0fc-7ec3-42c2-91b2-8418331dd0fc.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 62112-8045-2 62112804502 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (62112-8045-2) 2009-08-01 0000-00-00 No No Current