Prescription drug · ANDA
Acetazolamide NDC 10135-831
Acetazolamide 250 mg/1 · Tablet · Oral · Marlex Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-831-01 | 10135083101 | 100 TABLET in 1 BOTTLE (10135-831-01)Marketed from Feb 1, 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)
- Acetazolamide
- Generic name (nonproprietary)
- acetazolamide
- Active ingredients
- Acetazolamide — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Marlex Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217197
- Marketing start
- Listing expires
- Other FDA classes
- Carbonic Anhydrase Inhibitors (Mechanism)Sulfonamides (Chemical structure)
- Identifiers
- Product ID 10135-831_4a03f386-e570-d4cb-e063-6394a90a8228SPL ID 4a03f386-e570-d4cb-e063-6394a90a8228SPL set ID 4a03f35d-bfcb-77ff-e063-6294a90a4f06RxCUI 197303, 197304UNII O3FX965V0I
- Pharmacologic class
- Carbonic Anhydrase Inhibitor
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
N410135083101followed by a unit qualifier and the quantityPackage 10135-0831-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 217197
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 |
|---|---|---|---|---|
| Acetazolamide | Acetazolamide 125 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-830 |
| Acetazolamide | Acetazolamide 125 mg/1 | TabletOral | Aarkish Pharmaceuticals NJ Inc. | 81005-104 |
| Acetazolamide | Acetazolamide 250 mg/1 | TabletOral | Aarkish Pharmaceuticals NJ Inc. | 81005-105 |