Prescription drug · ANDA
acetazolamide NDC 70710-1591
Acetazolamide 500 mg/1 · Capsule · Oral · Zydus Pharmaceuticals (USA) Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1591-0 | 70710159100 | 1000 CAPSULE in 1 BOTTLE (70710-1591-0)Marketed from May 8, 2019 | |
| 70710-1591-1 | 70710159101 | 100 CAPSULE in 1 BOTTLE (70710-1591-1)Marketed from May 8, 2019 | |
| 70710-1591-3 | 70710159103 | 30 CAPSULE in 1 BOTTLE (70710-1591-3)Marketed from May 8, 2019 | |
| 70710-1591-4 | 70710159104 | 10 BLISTER PACK in 1 CARTON (70710-1591-4) / 10 CAPSULE in 1 BLISTER PACKMarketed from May 8, 2019 | |
| 70710-1591-5 | 70710159105 | 500 CAPSULE in 1 BOTTLE (70710-1591-5)Marketed from May 8, 2019 | |
| 70710-1591-9 | 70710159109 | 90 CAPSULE in 1 BOTTLE (70710-1591-9)Marketed from May 8, 2019 |
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
- Route
- Oral
- Labeler
- Zydus Pharmaceuticals (USA) Inc.NDC labeler code 70710
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205301
- Marketing start
- Listing expires
- Other FDA classes
- Carbonic Anhydrase Inhibitors (Mechanism)Sulfonamides (Chemical structure)
- Identifiers
- Product ID 70710-1591_4ee1e84b-1f11-43bb-8945-e6e302c58685SPL ID 4ee1e84b-1f11-43bb-8945-e6e302c58685SPL set ID bf514e99-4958-44a0-a87a-02a950f87e60RxCUI 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
N470710159100followed by a unit qualifier and the quantityPackage 70710-1591-00. 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.
About NDC 70710-1591
- What is NDC 70710-1591?
- 70710-1591 is the product NDC for acetazolamide, Acetazolamide 500 mg/1 capsule, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 6 package NDCs, 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?
- Zydus Pharmaceuticals (USA) Inc., NDC labeler code 70710. 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 205301
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 | CapsuleOral | Zydus Lifesciences Limited | 65841-762 |
| acetazolamide | Acetazolamide 500 mg/1 | CapsuleOral | American Health Packaging | 60687-578 |