Home NDC 42367-111 Diclofenac Sodium and Misoprostol
Product NDC 42367-111
11-digit product format 423670111
Labeler code 42367
Product ID 42367-111_a9cea5dd-d282-4ba2-ac44-d8b01eceffb1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Sodium and Misoprostol
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Eagle Pharmaceuticals, Inc.
Application ANDA200540
Marketing category ANDA
Marketing start 2014-07-15
Marketing end 0000-00-00
Substance DICLOFENAC SODIUM; MISOPROSTOL
Active strength 75 mg/1; mg/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 No
Listing certified through 2019-12-31
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 42367-111-06 Diclofenac Sodium and Misoprostol Delayed-Release 60 in 1 BOTTLE TABLET, DELAYED RELEASE 60 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Diclofenac sodium ACTIVE INGREDIENT QTG126297Q DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.] 3 Misoprostol ACTIVE INGREDIENT 0E43V0BB57 DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.] 3 Diclofenac ACTIVE MOIETY 144O8QL0L1 DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.] 3 Misoprostol ACTIVE MOIETY 0E43V0BB57 DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.] 3 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.] 3 hydrogenated castor oil INACTIVE INGREDIENT ZF94AP8MEY DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.] 3 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.] 3 isopropyl alcohol INACTIVE INGREDIENT ND2M416302 DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.] 3 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.] 3 methacrylic acid - ethyl acrylate copolymer (1:1) type a INACTIVE INGREDIENT NX76LV5T8J DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.] 3 povidone k30 INACTIVE INGREDIENT U725QWY32X DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.] 3 sodium starch glycolate type a potato INACTIVE INGREDIENT 5856J3G2A2 DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.] 3 starch, corn INACTIVE INGREDIENT O8232NY3SJ DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.] 3 talc INACTIVE INGREDIENT 7SEV7J4R1U DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.] 3 triethyl citrate INACTIVE INGREDIENT 8Z96QXD6UM DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42367-111 DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [EAGLE PHARMACEUTICALS, INC.] 3 Legacy NDC, 1 package rows 20140715_4616cae3-c91b-477c-94b0-d3f4468a59d9.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 42367-111-06 42367011106 60 in 1 BOTTLE Historical