Home NDC 10544-949 Diclofenac Sodium and Misoprostol
Product NDC 10544-949
11-digit product format 105440949
Labeler code 10544
Product ID 10544-949_219cc0f7-1a9c-689c-e054-00144ff88e88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Sodium and Misoprostol
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA201089
Marketing category ANDA
Marketing start 2015-10-07
Marketing end 0000-00-00
Substance DICLOFENAC SODIUM; MISOPROSTOL
Active strength 75 mg/1; ug/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 10544-949-14 Diclofenac Sodium and Misoprostol 14 in 1 BOTTLE, PLASTIC TABLET, DELAYED RELEASE 14 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DICLOFENAC SODIUM ACTIVE INGREDIENT QTG126297Q DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] 1 MISOPROSTOL ACTIVE INGREDIENT 0E43V0BB57 DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] 1 DICLOFENAC ACTIVE MOIETY 144O8QL0L1 DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] 1 MISOPROSTOL ACTIVE MOIETY 0E43V0BB57 DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] 1 CROSPOVIDONE (15 MPA.S AT 5%) INACTIVE INGREDIENT 68401960MK DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] 1 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] 1 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] 1 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-949 DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] 1 Legacy NDC, 1 package rows 20151008_219caa9b-96f2-643e-e054-00144ff88e88.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10544-949-14 10544094914 14 in 1 BOTTLE, PLASTIC Historical