Home NDC 66336-127 Nifedipine
Product NDC 66336-127
11-digit product format 663360127
Labeler code 66336
Product ID 66336-127_753fe817-2105-4f60-8144-5f2560496201
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nifedipine
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Dispensing Solutions, Inc.
Application ANDA077410
Marketing category ANDA
Marketing start 2007-10-03
Marketing end 0000-00-00
Substance NIFEDIPINE
Active strength 90 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 66336-127-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 66336-127-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 66336-127-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 66336-127-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 66336-127-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 66336-127-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 66336-127-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 66336-127-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 66336-127-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 66336-127-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 66336-127-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 66336-127-30 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 66336-127-30 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 66336-127-30 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 66336-127-30 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 66336-127-30 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 66336-127-30 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 66336-127-30 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 66336-127-30 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 66336-127-30 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 66336-127-30 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 66336-127-30 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog .
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 66336-127-30 Nifedipine 30 in 1 BOTTLE TABLET, FILM COATED, EXTENDED RE 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NIFEDIPINE ACTIVE INGREDIENT I9ZF7L6G2L NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] 1 NIFEDIPINE ACTIVE MOIETY I9ZF7L6G2L NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] 1 CELLULOSE ACETATE INACTIVE INGREDIENT 3J2P07GVB6 NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66336-127 NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.] 1 Legacy NDC, 1 package rows 20130827_29948343-80fc-4369-9a83-2ee0d94cb1ea.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 Status 66336-127-30 66336012730 30 in 1 BOTTLE Historical