Prescription drug · ANDA
acetazolamide NDC 0904-6663
Acetazolamide 250 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6663-61 | 00904666361 | 100 BLISTER PACK in 1 CARTON (0904-6663-61) / 1 TABLET in 1 BLISTER PACKMarketed from Mar 15, 2013 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205530
- Marketing start
- Listing expires
- Other FDA classes
- Carbonic Anhydrase Inhibitors (Mechanism)Sulfonamides (Chemical structure)
- Identifiers
- Product ID 0904-6663_17b05236-812a-49a8-a7c5-0b5c7c311dd3SPL ID 17b05236-812a-49a8-a7c5-0b5c7c311dd3SPL set ID 37135ba5-63fd-427f-9b4a-8b7d1009bbcaRxCUI 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
N400904666361followed by a unit qualifier and the quantityPackage 00904-6663-61. 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.
About NDC 0904-6663
- What is NDC 0904-6663?
- 0904-6663 is the product NDC for acetazolamide, Acetazolamide 250 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- acetazolamide.
- What is the active ingredient?
- Acetazolamide.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for acetazolamide?
- 71 other product NDCs are listed under this name. See all acetazolamide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other acetazolamide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Acetazolamideacetazolamide sodium | Acetazolamide sodium 500 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 72078-092 | 72078-0092-50 |
| Acetazolamide | Acetazolamide 500 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4646 | 70518-4646-00 |
| Acetazolamide | Acetazolamide 125 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-830 | 10135-0830-01 |
| Acetazolamide | Acetazolamide 250 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-831 | 10135-0831-01 |
| Acetazolamideacetazolamide sodium | Acetazolamide sodium 500 mg/5mL | Injection, Powder, For solutionIntravenous | Sagent Pharmaceuticals | 25021-839 | 25021-0839-20 |
| Acetazolamide | Acetazolamide sodium 500 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-661 | 68083-0661-01 |
| Acetazolamide | Acetazolamide 125 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-905 | 59651-0905-01 |
| Acetazolamide | Acetazolamide 250 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-906 | 59651-0906-01 |
| Acetazolamide | Acetazolamide 125 mg/1 | TabletOral | Aarkish Pharmaceuticals NJ Inc. | 81005-104 | 81005-0104-0181005-0104-10 |
| Acetazolamide | Acetazolamide 250 mg/1 | TabletOral | Aarkish Pharmaceuticals NJ Inc. | 81005-105 | 81005-0105-0181005-0105-10 |
Other NDCs under ANDA 205530
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 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-287 |
| acetazolamide | Acetazolamide 250 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-288 |
| acetazolamide | Acetazolamide 125 mg/1 | TabletOral | AvKARE | 42291-089 |
| acetazolamide | Acetazolamide 250 mg/1 | TabletOral | AvKARE | 42291-090 |
| acetazolamide | Acetazolamide 125 mg/1 | TabletOral | A-S Medication Solutions | 50090-5617 |
| acetazolamide | Acetazolamide 125 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-331 |
| Acetazolamide | Acetazolamide 125 mg/1 | TabletOral | Chartwell RX, LLC | 62135-607 |
| Acetazolamide | Acetazolamide 250 mg/1 | TabletOral | Chartwell RX, LLC | 62135-608 |