Prescription drug · ANDA
Acetazolamide NDC 50268-054
Acetazolamide 250 mg/1 · Tablet · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-054-15 | 50268005415 | 50 BLISTER PACK in 1 BOX (50268-054-15) / 1 TABLET in 1 BLISTER PACK (50268-054-11)Marketed from Jul 7, 2020 |
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
- AvPAK
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209734
- Marketing start
- Listing expires
- Other FDA classes
- Carbonic Anhydrase Inhibitors (Mechanism)Sulfonamides (Chemical structure)
- Identifiers
- Product ID 50268-054_47e22404-7bca-908d-e063-6294a90a70c1SPL ID 47e22404-7bca-908d-e063-6294a90a70c1SPL set ID a9dca448-5511-413e-e053-2a95a90a8c66RxCUI 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
N450268005415followed by a unit qualifier and the quantityPackage 50268-0054-15. 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 For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide Tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209734
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 | Proficient Rx LP | 71205-308 |
| Acetazolamide | Acetazolamide 125 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-045 |
| Acetazolamide | Acetazolamide 250 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-834 |
| Acetazolamide | Acetazolamide 125 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-833 |
| Acetazolamide | Acetazolamide 250 mg/1 | TabletOral | A-S Medication Solutions | 50090-5593 |
| Acetazolamide | Acetazolamide 125 mg/1 | TabletOral | NuCare Pharmaceuticlas, Inc. | 68071-3728 |