Prescription drug · ANDA
Acetazolamide Extended-Release NDC 50268-042
Acetazolamide 500 mg/1 · Capsule · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-042-12 | 50268004212 | 20 BLISTER PACK in 1 BOX (50268-042-12) / 1 CAPSULE in 1 BLISTER PACK (50268-042-11)Marketed from Jul 20, 2022 |
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 Extended-Release
- Generic name (nonproprietary)
- acetazolamide extended-release
- Active ingredients
- Acetazolamide — 500 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- AvPAK
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207401
- Marketing start
- Listing expires
- Other FDA classes
- Carbonic Anhydrase Inhibitors (Mechanism)Sulfonamides (Chemical structure)
- Identifiers
- Product ID 50268-042_0e84c7df-dbb4-d445-e063-6394a90ab528SPL ID 0e84c7df-dbb4-d445-e063-6394a90ab528SPL set ID e43f991d-15b9-1e66-e053-2a95a90a9449RxCUI 562524UNII 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
N450268004212followed by a unit qualifier and the quantityPackage 50268-0042-12. 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: chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angleclosure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide extended-release capsules are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness despite gradual ascent.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207401
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 Extended-Release | Acetazolamide 500 mg/1 | CapsuleOral | Micro Labs Limited | 42571-243 |