NDC codes

FDA NDC Directory
Product NDC (as listed)71993-312Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71993-0312Add 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 NDC11-digit (billing)PackageCopy
71993-312-307199303123030 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
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

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

N471993031230 followed by a unit qualifier and the quantity

Package 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.

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
ProductStrengthForm · routeLabelerProduct NDC
Tolectintolmetin sodiumTolmetin sodium 600 mg/1Tablet, Film coatedOralPoly Pharmaceuticals, Inc.50991-988

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