Prescription drug · ANDA
Tolmetin Sodium NDC 71993-312
Tolmetin sodium 600 mg/1 · Tablet, Film coated · Oral · Atland Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71993-312-30 | 71993031230 | 30 TABLET, FILM COATED in 1 BOTTLE (71993-312-30)Marketed from Feb 25, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Tolmetin Sodium
- Generic name (nonproprietary)
- tolmetin sodium
- Active ingredients
- Tolmetin sodium — 600 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Atland Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074473
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 71993-312_24ffd8d5-f836-4914-b4d9-1cc420e01fa3SPL ID 24ffd8d5-f836-4914-b4d9-1cc420e01fa3SPL set ID e6150446-c5ef-4437-b488-067876649fccRxCUI 198297UNII 02N1TZF99FUPC 0371993312303
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471993031230followed by a unit qualifier and the quantityPackage 71993-0312-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE: Carefully consider the potential benefits and risks of tolmetin sodium tablets, USP and other treatment options before deciding to use tolmetin sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Tolmetin sodium tablets are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. Tolmetin sodium tablets are indicated in the treatment of acute flares and the long-term management of the chronic disease. Tolmetin sodium tablets are also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of tolmetin sodium tablets hav…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074473
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tolectintolmetin sodium | Tolmetin sodium 600 mg/1 | Tablet, Film coatedOral | Poly Pharmaceuticals, Inc. | 50991-988 |