TOLMETIN SODIUM

Product NDC
61825-310
11-digit product format
618250310
Labeler code
61825
Product ID
61825-310_4d9de430-f193-a927-e063-6294a90a14d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOLMETIN SODIUM
Dosage form
CAPSULE
Route
ORAL
Labeler
Galt Pharmaceuticals, LLC
Application
ANDA073393
Marketing category
ANDA
Marketing start
2026-03-19
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TOLMETIN SODIUM
Listing expiration
2027-12-31

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
61825-310-30TOLMETIN SODIUM30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61825-310-30EA - Each61825-31000ff96ca-875a-4c29-83a7-540df50119ec12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198296tolmetin sodium 400 MG Oral CapsulePSN0a97800f-706d-4787-98fe-08dadf9c4d5f1
198296tolmetin 400 MG Oral CapsuleSCD0a97800f-706d-4787-98fe-08dadf9c4d5f1
198296tolmetin 400 MG (as tolmetin sodium dihydrate 492 MG) Oral CapsuleSY0a97800f-706d-4787-98fe-08dadf9c4d5f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61825-310-306182503103030 CAPSULE in 1 BOTTLE (61825-310-30) 30 capsule2026-03-19NoNoCurrent