Prescription drug · ANDA
Acetazolamide NDC 68083-661
Acetazolamide sodium 500 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-661-01 | 68083066101 | 1 VIAL in 1 CARTON (68083-661-01) / 5 mL in 1 VIALMarketed from Jun 17, 2025 |
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 sodium — 500 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219775
- Marketing start
- Listing expires
- Other FDA classes
- Carbonic Anhydrase Inhibitors (Mechanism)Sulfonamides (Chemical structure)
- Identifiers
- Product ID 68083-661_de1a5d68-b82d-4a84-9362-f7edd73f377aSPL ID de1a5d68-b82d-4a84-9362-f7edd73f377aSPL set ID 2b9fb0dd-e42e-4f9b-bf24-98b268d877e5RxCUI 307702UNII 429ZT169UHUPC 0368083661014
- 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
N468083066101followed by a unit qualifier and the quantityPackage 68083-0661-01. 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: 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 68083-661
- What is NDC 68083-661?
- 68083-661 is the product NDC for Acetazolamide, Acetazolamide sodium 500 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Gland Pharma Limited. 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 sodium.
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. 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?
- 70 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) |
|---|---|---|---|---|---|
| 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 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 |
| Acetazolamide | Acetazolamide 125 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-132 | 27241-0132-04 |
| Acetazolamide | Acetazolamide 250 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-133 | 27241-0133-04 |
Other NDCs under ANDA 219775
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, For solutionIntravenous | Sagent Pharmaceuticals | 25021-839 |