Tolectin (tolmetin sodium) NDC 50991-988

NDC codes

FDA NDC Directory

Product NDC (as listed)50991-988Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50991-0988Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
50991-988-30	50991098830	30 TABLET, FILM COATED in 1 BOTTLE (50991-988-30)Marketed from Apr 4, 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): Tolectin
Generic name (nonproprietary): tolmetin sodium
Active ingredients: Tolmetin sodium — 600 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Poly Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074473
Marketing start: Apr 4, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 50991-988_472dd96d-50bb-e82c-e063-6294a90af66dSPL ID 472dd96d-50bb-e82c-e063-6294a90af66dSPL set ID 15467b19-e43a-5be9-e063-6294a90a3ccaRxCUI 198297, 208048UNII 02N1TZF99FUPC 0350991988307
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

N450991098830 followed by a unit qualifier and the quantity

Package 50991-0988-30. 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 Dec 30, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & USAGE Carefully consider the potential benefits and risks of TOLECTIN tablets, USP and other treatment options before deciding to use TOLECTIN tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). TOLECTIN tablets are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. TOLECTIN tablets are indicated in the treatment of acute flares and the long-term management of the chronic disease. TOLECTIN tablets are also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of TOLECTIN tablets have not been established in pediatric patients …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 074473

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 074473
Product	Strength	Form · route	Labeler	Product NDC
Tolmetin Sodium	Tolmetin sodium 600 mg/1	Tablet, Film coatedOral	Atland Pharmaceuticals, LLC	71993-312