Prescription drug · ANDA
Tolmetin Sodium NDC 71993-309
Tolmetin sodium 400 mg/1 · Capsule · Oral · Atland Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71993-309-30 | 71993030930 | 30 CAPSULE in 1 BOTTLE (71993-309-30)Marketed from Apr 5, 2024 |
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 — 400 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Atland Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 073393
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 71993-309_abeefa75-1276-43da-b344-90d478c022fcSPL ID abeefa75-1276-43da-b344-90d478c022fcSPL set ID 41b7704e-25a1-45e8-93c0-9ac2f0effef9RxCUI 198296UNII 02N1TZF99FUPC 0371993309303
- 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
N471993030930followed by a unit qualifier and the quantityPackage 71993-0309-30. 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 capsules, USP and other treatment options before deciding to use tolmetin sodium capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Tolmetin sodium capsules are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. Tolmetin sodium capsules are indicated in the treatment of acute flares and the long-term management of the chronic disease. Tolmetin sodium capsules are also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of tolmetin sodium capsul…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 073393
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 |
|---|---|---|---|---|
| Tolmetin Sodium | Tolmetin sodium 400 mg/1 | CapsuleOral | Galt Pharmaceuticals, LLC | 61825-310 |