Prescription drug · ANDA
balsalazide disodium NDC 70771-1841
Balsalazide disodium 750 mg/1 · Capsule · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1841-1 | 70771184101 | 280 CAPSULE in 1 BOTTLE (70771-1841-1)Marketed from Aug 25, 2023 |
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)
- balsalazide disodium
- Generic name (nonproprietary)
- balsalazide disodium
- Active ingredients
- Balsalazide disodium — 750 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217592
- Marketing start
- Listing expires
- Other FDA classes
- Aminosalicylic Acids (Chemical structure)
- Identifiers
- Product ID 70771-1841_1e89905a-c8b9-4083-b5de-2b6429482dd9SPL ID 1e89905a-c8b9-4083-b5de-2b6429482dd9SPL set ID c573888c-4aa3-4fdb-bf3f-1cf3d78d922bRxCUI 885857UNII 1XL6BJI034
- Pharmacologic class
- Aminosalicylate
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
N470771184101followed by a unit qualifier and the quantityPackage 70771-1841-01. 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)
Balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Limitations of Use Safety and effectiveness of balsalazide disodium capsules beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established. Balsalazide disodium capsules are an aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. ( 1 ) Limitations of Use: Safety and effectiveness of balsalazide disodium capsules beyond 8 weeks in children (ages 5 years to 17 years) and 12 weeks in adults have not been established. ( …
Excerpt only. Read the full label for complete information.
About NDC 70771-1841
- What is NDC 70771-1841?
- 70771-1841 is the product NDC for balsalazide disodium, Balsalazide disodium 750 mg/1 capsule, listed with the FDA by Zydus Lifesciences Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- balsalazide disodium.
- What is the active ingredient?
- Balsalazide disodium.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for balsalazide disodium?
- 8 other product NDCs are listed under this name. See all balsalazide disodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other balsalazide disodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| balsalazide disodium | Balsalazide disodium 750 mg/1 | CapsuleOral | Carnegie Pharmaceuticals, LLC | 80005-126 | 80005-0126-25 |
| balsalazide disodium | Balsalazide disodium 750 mg/1 | CapsuleOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1626 | 70710-1626-01 |
| Balsalazide Disodium | Balsalazide disodium 750 mg/1 | CapsuleOral | AvPAK | 50268-102 | 50268-0102-13 |
| Balsalazide Disodium | Balsalazide disodium 750 mg/1 | CapsuleOral | Hikma Pharmaceuticals USA Inc. | 0054-0079 | 00054-0079-28 |
| Balsalazide Disodium | Balsalazide disodium 750 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-820 | 51407-0820-28 |
| Balsalazide Disodium | Balsalazide disodium 750 mg/1 | CapsuleOral | Apotex Corp. | 60505-2575 | 60505-2575-0060505-2575-0360505-2575-04+1 more |
| Balsalazide Disodium | Balsalazide disodium 750 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2095 | 72162-2095-02 |
| Balsalazide Disodium | Balsalazide disodium 750 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-149 | 72789-0149-69 |
Other NDCs under ANDA 217592
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 |
|---|---|---|---|---|
| balsalazide disodium | Balsalazide disodium 750 mg/1 | CapsuleOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1626 |