Home NDC 55289-907-30 Nifedipine
Product NDC 55289-907
Requested package NDC 55289-907-30
11-digit product format 552890907
Labeler code 55289
Product ID 55289-907_d2942db2-ea00-803c-e053-2995a90a9153
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nifedipine
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA072781
Marketing category ANDA
Marketing start 2009-08-11
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 2022-12-31
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 · 12 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…
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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NIFEDIPINE ACTIVE INGREDIENT I9ZF7L6G2L NIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 NIFEDIPINE ACTIVE MOIETY I9ZF7L6G2L NIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD NIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 NIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L NIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 MENTHOL INACTIVE INGREDIENT L7T10EIP3A NIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X NIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O NIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 SORBITAN INACTIVE INGREDIENT 6O92ICV9RU NIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R NIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R NIFEDIPINE (NIFEDIPINE) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 2
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55289-907-30 55289090730 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-907-30) 30 capsule 2009-08-11 0000-00-00 No No Current