Prescription drug · ANDA
Tolmetin Sodium NDC 61825-310
Tolmetin sodium 400 mg/1 · Capsule · Oral · Galt Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61825-310-30 | 61825031030 | 30 CAPSULE in 1 BOTTLE (61825-310-30)Marketed from Mar 19, 2026 |
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
- Galt 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 61825-310_4d9de430-f193-a927-e063-6294a90a14d4SPL ID 4d9de430-f193-a927-e063-6294a90a14d4SPL set ID 0a97800f-706d-4787-98fe-08dadf9c4d5fRxCUI 198296UNII 02N1TZF99FUPC 0361825310300
- 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
N461825031030followed by a unit qualifier and the quantityPackage 61825-0310-30. 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 TOLECTIN capsules, USP and other treatment options before deciding to use TOLECTIN capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). TOLECTIN capsules are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. TOLECTIN capsules are indicated in the treatment of acute flares and the long-term management of the chronic disease. TOLECTIN capsules are also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of TOLECTIN capsules have not been established in pediatric …
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 | Atland Pharmaceuticals, LLC | 71993-309 |
- openFDA data updated
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