Home NDC 21695-425 ARTHROTEC
Product NDC 21695-425
11-digit product format 216950425
Labeler code 21695
Product ID 21695-425_0d527c1c-19c5-4199-a51d-b953798d42a3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diclofenac sodium and misoprostol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rebel Distributors Corp.
Application NDA020607
Marketing category NDA
Marketing start 1997-12-24
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 21695-425-60 ARTHROTEC 60 in 1 BOTTLE TABLET, FILM COATED 60 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded diclofenac sodium ACTIVE INGREDIENT QTG126297Q ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 misoprostol ACTIVE INGREDIENT 0E43V0BB57 ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 diclofenac ACTIVE MOIETY 144O8QL0L1 ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 misoprostol ACTIVE MOIETY 0E43V0BB57 ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 crospovidone INACTIVE INGREDIENT 68401960MK ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 hydrogenated castor oil INACTIVE INGREDIENT ZF94AP8MEY ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 hypromellose INACTIVE INGREDIENT 3NXW29V3WO ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 lactose INACTIVE INGREDIENT J2B2A4N98G ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 povidone K30 INACTIVE INGREDIENT U725QWY32X ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 starch, corn INACTIVE INGREDIENT O8232NY3SJ ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 talc INACTIVE INGREDIENT 7SEV7J4R1U ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 triethyl citrate INACTIVE INGREDIENT 8Z96QXD6UM ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21695-425 ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] 1 Legacy NDC, 1 package rows 20091123_1cdede45-4e2b-490a-bd22-eca5315af316.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 21695-425-60 21695042560 60 in 1 BOTTLE Historical