Prescription drug · ANDA
Acetazolamide NDC 63629-1194
Acetazolamide 125 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-1194-1 | 63629119401 | 100 TABLET in 1 BOTTLE (63629-1194-1)Marketed from Oct 29, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 125 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214282
- Marketing start
- Listing expires
- Other FDA classes
- Carbonic Anhydrase Inhibitors (Mechanism)Sulfonamides (Chemical structure)
- Identifiers
- Product ID 63629-1194_e31047fd-d413-4eaf-a956-9e58acc0e534SPL ID e31047fd-d413-4eaf-a956-9e58acc0e534SPL set ID f7227cc5-0a80-47df-baf8-09f1b22b187eRxCUI 197303UNII 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
N463629119401followed by a unit qualifier and the quantityPackage 63629-1194-01. 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 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 214282
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 250 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1195 |
| Acetazolamide | Acetazolamide 125 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1978 |
| Acetazolamide | Acetazolamide 250 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1979 |
| Acetazolamide | Acetazolamide 125 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-720 |
| Acetazolamide | Acetazolamide 250 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-721 |