NDC 53489-507

TOLMETIN SODIUM

Tolmetin Sodium

TOLMETIN SODIUM is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Mutual Pharmaceutical Company, Inc.. The primary component is Tolmetin Sodium.

Product ID53489-507_e030ea24-4db5-4eb4-9dc5-b4397c29cb60
NDC53489-507
Product TypeHuman Prescription Drug
Proprietary NameTOLMETIN SODIUM
Generic NameTolmetin Sodium
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2009-09-04
Marketing CategoryANDA / ANDA
Application NumberANDA073311
Labeler NameMutual Pharmaceutical Company, Inc.
Substance NameTOLMETIN SODIUM
Active Ingredient Strength400 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53489-507-03

250 CAPSULE in 1 BOTTLE, PLASTIC (53489-507-03)
Marketing Start Date2009-09-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53489-507-01 [53489050701]

TOLMETIN SODIUM CAPSULE
Marketing CategoryANDA
Application NumberANDA073311
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-04
Marketing End Date2009-09-30

NDC 53489-507-05 [53489050705]

TOLMETIN SODIUM CAPSULE
Marketing CategoryANDA
Application NumberANDA073311
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-04
Marketing End Date2009-09-30

NDC 53489-507-10 [53489050710]

TOLMETIN SODIUM CAPSULE
Marketing CategoryANDA
Application NumberANDA073311
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-04
Marketing End Date2009-09-30

NDC 53489-507-03 [53489050703]

TOLMETIN SODIUM CAPSULE
Marketing CategoryANDA
Application NumberANDA073311
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-04
Marketing End Date2009-09-30

Drug Details

Active Ingredients

IngredientStrength
TOLMETIN SODIUM400 mg/1

OpenFDA Data

SPL SET ID:a6c72634-4613-4d21-bc9a-09dad17eb137
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198295
  • 198296

    • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

    NDC Crossover Matching brand name "TOLMETIN SODIUM" or generic name "Tolmetin Sodium"

    NDCBrand NameGeneric Name
    0378-0313Tolmetin Sodiumtolmetin sodium
    0378-5200Tolmetin Sodiumtolmetin Sodium
    53489-506TOLMETIN SODIUMtolmetin sodium
    53489-507TOLMETIN SODIUMtolmetin sodium
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