Tolmetin Sodium

Product NDC
71993-309
11-digit product format
719930309
Labeler code
71993
Product ID
71993-309_abeefa75-1276-43da-b344-90d478c022fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolmetin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Atland Pharmaceuticals, LLC
Application
ANDA073393
Marketing category
ANDA
Marketing start
2024-04-05
Substance
TOLMETIN SODIUM
Active strength
400 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 SODIUM400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii02N1TZF99F
Rxcui198296

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
71993-309-30Tolmetin Sodium30 in 1 BOTTLECAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71993-309-30EA - Each71993-309fa7bb74d-00aa-4439-be62-17cb2236546412024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71993-309TOLMETIN SODIUM CAPSULE [ATLAND PHARMACEUTICALS, LLC]2Current NDC, 1 package rows20250328_41b7704e-25a1-45e8-93c0-9ac2f0effef9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198296tolmetin sodium 400 MG Oral CapsulePSN41b7704e-25a1-45e8-93c0-9ac2f0effef92
198296tolmetin 400 MG Oral CapsuleSCD41b7704e-25a1-45e8-93c0-9ac2f0effef92
198296tolmetin 400 MG (as tolmetin sodium dihydrate 492 MG) Oral CapsuleSY41b7704e-25a1-45e8-93c0-9ac2f0effef92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71993-309-307199303093030 CAPSULE in 1 BOTTLE (71993-309-30) 30 capsule2024-04-05NoNoHistorical