Home NDC 50268-599-15 Nifedipine
Product NDC 50268-599
Requested package NDC 50268-599-15
11-digit product format 502680599
Labeler code 50268
Product ID 50268-599_47e7d21f-e346-6413-e063-6294a90aa9be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nifedipine
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler AvPAK
Application ANDA077410
Marketing category ANDA
Marketing start 2011-02-11
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog .
Additional Listing Data#
Finished product Yes
Brand name base Nifedipine
Brand name suffix ER
Listing expiration 2027-12-31 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1812011 Internal RxNorm lookup 1812013 Internal RxNorm lookup 1812015 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50268-599-11 NifedipineER 1 in 1 BLISTER PACK TABLET, FILM COATED, EXTENDED RE 1 16 50268-599-15 NifedipineER 50 in 1 BOX, UNIT-DOSE TABLET, FILM COATED, EXTENDED RE 50 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Nifedipine ACTIVE INGREDIENT I9ZF7L6G2L NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK] 9 Nifedipine ACTIVE MOIETY I9ZF7L6G2L NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK] 9 Cellulose Acetate INACTIVE INGREDIENT 3J2P07GVB6 NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK] 9 Cellulose, Microcrystalline INACTIVE INGREDIENT OP1R32D61U NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK] 9 Ferric Oxide Red INACTIVE INGREDIENT 1K09F3G675 NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK] 9 Ferrosoferric Oxide INACTIVE INGREDIENT XM0M87F357 NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK] 9 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK] 9 Lactose Monohydrate INACTIVE INGREDIENT EWQ57Q8I5X NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK] 9 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK] 9 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK] 9 Polysorbate 20 INACTIVE INGREDIENT 7T1F30V5YH NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK] 9 Povidone INACTIVE INGREDIENT FZ989GH94E NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK] 9 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK] 9 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK] 9 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK] 9 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK] 9 Triacetin INACTIVE INGREDIENT XHX3C3X673 NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50268-599 NIFEDIPINE ER (NIFEDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [AVPAK] 15 Current NDC, Legacy NDC, 2 package rows 20220119_d1a78ff2-7672-3e69-00ef-63d203c80484.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 Units Marketing start Marketing end Sample Exclude flag Status 50268-599-15 50268059915 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-599-15) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (50268-599-11) 50 blister pack 2011-02-11 0000-00-00 No No Current