Tolmetin Sodium

Product NDC
71993-312
11-digit product format
719930312
Labeler code
71993
Product ID
71993-312_24ffd8d5-f836-4914-b4d9-1cc420e01fa3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolmetin Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Atland Pharmaceuticals, LLC
Application
ANDA074473
Marketing category
ANDA
Marketing start
2025-02-25
Substance
TOLMETIN SODIUM
Active strength
600 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tolmetin Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLMETIN SODIUM600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii02N1TZF99F
Rxcui198297

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ad3a5dc6-863f-442d-2886-f8a057d6cb13Product name120140508
e10d0ded-5358-1a18-d5a9-92245cfbbbf9Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71993-312-30Tolmetin Sodium30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71993-312-30EA - Each71993-312d616f6a0-7f47-483c-8b92-1492a390ca2112025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71993-312TOLMETIN SODIUM TABLET, FILM COATED [ATLAND PHARMACEUTICALS, LLC]3Current NDC, 1 package rows20250402_e6150446-c5ef-4437-b488-067876649fcc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198297tolmetin sodium 600 MG Oral TabletPSNe6150446-c5ef-4437-b488-067876649fcc3
198297tolmetin 600 MG Oral TabletSCDe6150446-c5ef-4437-b488-067876649fcc3
198297tolmetin 600 MG (as tolmetin sodium 738 MG) Oral TabletSYe6150446-c5ef-4437-b488-067876649fcc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71993-312-307199303123030 TABLET, FILM COATED in 1 BOTTLE (71993-312-30) 2025-02-25NoNoCurrent