NDC 42571-134

Diclofenac Sodium/Misoprostol diclofenac-sodium-misoprostol

Diclofenac Sodium/misoprostol

Diclofenac Sodium/Misoprostol diclofenac-sodium-misoprostol is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Micro Labs Limited. The primary component is Diclofenac Sodium; Misoprostol.

Product ID42571-134_c91bba4c-accf-214a-e053-2a95a90a34b6
NDC42571-134
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium/Misoprostol diclofenac-sodium-misoprostol
Generic NameDiclofenac Sodium/misoprostol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2021-09-01
Marketing CategoryANDA /
Application NumberANDA204355
Labeler NameMicro Labs Limited
Substance NameDICLOFENAC SODIUM; MISOPROSTOL
Active Ingredient Strength75 mg/1; ug/1
Pharm ClassesCyclooxygenase 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 FlagN
Listing Certified Through2022-12-31

Packaging

NDC 42571-134-29

60 BLISTER PACK in 1 CARTON (42571-134-29) > 10 TABLET in 1 BLISTER PACK
Marketing Start Date2021-09-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Diclofenac Sodium/Misoprostol diclofenac-sodium-misoprostol" or generic name "Diclofenac Sodium/misoprostol"

NDCBrand NameGeneric Name
42571-133Diclofenac Sodium/MisoprostolDiclofenac Sodium/Misoprostol
42571-134Diclofenac Sodium/MisoprostolDiclofenac Sodium/Misoprostol
68788-8214Diclofenac Sodium/MisoprostolDiclofenac Sodium/Misoprostol

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