Prescription drug · ANDA
Acetazolamide NDC 70518-4646
Acetazolamide 500 mg/1 · Capsule, Extended release · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4646-0 | 70518464600 | 50 POUCH in 1 BOX (70518-4646-0) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-4646-1)Marketed from Apr 28, 2026 |
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 — 500 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040904
- Marketing start
- Listing expires
- Other FDA classes
- Carbonic Anhydrase Inhibitors (Mechanism)Sulfonamides (Chemical structure)
- Identifiers
- Product ID 70518-4646_508b15b8-2f21-c075-e063-6394a90af64dSPL ID 508b15b8-2f21-c075-e063-6394a90af64dSPL set ID fb2cf8fe-da81-445e-a18b-9aa9ced1d34aRxCUI 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
N470518464600followed by a unit qualifier and the quantityPackage 70518-4646-00. 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 040904
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 | A-S Medication Solutions | 50090-5945 |
| Acetazolamide | Acetazolamide 500 mg/1 | Capsule, Extended releaseOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-787 |
| Acetazolamide | Acetazolamide 500 mg/1 | Capsule, Extended releaseOral | Chartwell RX, LLC | 62135-612 |