Prescription drug · ANDA
Acetazolamide (Acetazolamide sodium) NDC 67457-853
Acetazolamide sodium 500 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-853-50 | 67457085350 | 1 VIAL in 1 CARTON (67457-853-50) / 5 mL in 1 VIALMarketed from Sep 13, 2018 |
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 sodium
- Active ingredients
- Acetazolamide sodium — 500 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Mylan Institutional LLCNDC labeler code 67457
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200880
- Marketing start
- Listing expires
- Other FDA classes
- Carbonic Anhydrase Inhibitors (Mechanism)Sulfonamides (Chemical structure)
- Identifiers
- Product ID 67457-853_300661cb-a5d8-4edc-a191-72284744e1ebSPL ID 300661cb-a5d8-4edc-a191-72284744e1ebSPL set ID 521838b0-a10d-495f-a014-f9ff25a6b6f3RxCUI 307702UNII 429ZT169UH
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N467457085350followed by a unit qualifier and the quantityPackage 67457-0853-50. 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.
Excerpt only. Read the full label for complete information.
About NDC 67457-853
- What is NDC 67457-853?
- 67457-853 is the product NDC for Acetazolamide (acetazolamide sodium), Acetazolamide sodium 500 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetazolamide (Acetazolamide sodium).
- What is the active ingredient?
- Acetazolamide sodium.
- Who is the labeler?
- Mylan Institutional LLC, NDC labeler code 67457. 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 200880
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 |
|---|---|---|---|---|
| Acetazolamideacetazolamide sodium | Acetazolamide sodium 500 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 72078-092 |