Prescription drug · ANDA
acetazolamide NDC 16729-331
Acetazolamide 500 mg/1 · Capsule, Extended release · Oral · Accord Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-331-01 | 16729033101 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16729-331-01)Marketed from Nov 19, 2021 |
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 — 500 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Accord Healthcare Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207659
- Marketing start
- Listing expires
- Other FDA classes
- Carbonic Anhydrase Inhibitors (Mechanism)Sulfonamides (Chemical structure)
- Identifiers
- Product ID 16729-331_45ffaa19-26c0-d41f-e063-6394a90ad7c3SPL ID 45ffaa19-26c0-d41f-e063-6394a90ad7c3SPL set ID 9a368b35-cd51-47ad-83cc-ccc56c4585e8RxCUI 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
N416729033101followed by a unit qualifier and the quantityPackage 16729-0331-01. 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: 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 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 207659
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 500 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-9729 |