Prescription drug · ANDA
Probenecid NDC 10135-541
Probenecid 500 mg/1 · Tablet, Film coated · Oral · Marlex Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-541-01 | 1013505410110135054101 | 100 TABLET, FILM COATED in 1 BOTTLE (10135-541-01)Marketed from Jul 29, 1976 | |
| 10135-541-10 | 1013505411010135054110 | 1000 TABLET, FILM COATED in 1 BOTTLE (10135-541-10)Marketed from Jul 29, 1976 |
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)
- Probenecid
- Generic name (nonproprietary)
- probenecid
- Active ingredients
- Probenecid — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Marlex Pharmaceuticals IncNDC labeler code 10135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080966
- Marketing start
- Listing expires
- Identifiers
- Product ID 10135-541_43e0b999-0f40-3c9d-e063-6294a90ae477SPL ID 43e0b999-0f40-3c9d-e063-6294a90ae477SPL set ID 5d552de5-2d18-4464-bcaf-0311fa3f080dRxCUI 198152UNII PO572Z7917
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
N410135054101followed by a unit qualifier and the quantityPackage 10135-0541-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Probenecid tablets are indicated for the treatment of the hyperuricemia associated with gout and gouty arthritis. As an adjuvant to therapy with penicillin or with ampicillin, methicillin, oxacillin, cloxacillin, or nafcillin, for elevation and prolongation of plasma levels by whatever route the antibiotic is given.
Excerpt only. Read the full label for complete information.
About NDC 10135-541
- What is NDC 10135-541?
- 10135-541 is the product NDC for Probenecid, Probenecid 500 mg/1 tablet, film coated, listed with the FDA by Marlex Pharmaceuticals Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Probenecid.
- What is the active ingredient?
- Probenecid.
- Who is the labeler?
- Marlex Pharmaceuticals Inc, NDC labeler code 10135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Probenecid?
- 6 other product NDCs are listed under this name. See all Probenecid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Probenecid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Probenecid | Probenecid 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4649 | 70518-4649-00 |
| Probenecid | Probenecid 500 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-831 | 16571-0831-0116571-0831-10 |
| Probenecid | Probenecid 500 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2386 | 72162-2386-01 |
| Probenecid | Probenecid 500 mg/1 | Tablet, Film coatedOral | Actavis Pharma, Inc. | 0591-5347 | 00591-5347-0100591-5347-10 |
| Probenecid | Probenecid 500 mg/1 | Tablet, Film coatedOral | Lannett Company, Inc. | 0527-1367 | 00527-1367-0100527-1367-10 |
| Probenecid | Probenecid 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2237 | 72162-2237-01 |
Other NDCs under ANDA 080966
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 |
|---|---|---|---|---|
| Probenecid | Probenecid 500 mg/1 | Tablet, Film coatedOral | Lannett Company, Inc. | 0527-1367 |
| Probenecid | Probenecid 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2237 |