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Tolmetin Sodium

Tolmetin Sodium Tablets, USP 600 mg Rx only

Approved
Approval ID

e6150446-c5ef-4437-b488-067876649fcc

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 31, 2025

Manufacturers
FDA

Atland Pharmaceuticals, LLC

DUNS: 080942150

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tolmetin Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71993-312
Application NumberANDA074473
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tolmetin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2025
FDA Product Classification

INGREDIENTS (15)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
TOLMETIN SODIUMActive
Quantity: 600 mg in 1 1
Code: 02N1TZF99F
Classification: ACTIM

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Tolmetin Sodium - FDA Drug Approval Details