NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1841Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1841Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70771-1841-170771184101280 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

N470771184101 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other balsalazide disodium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
balsalazide disodiumBalsalazide disodium 750 mg/1CapsuleOralCarnegie Pharmaceuticals, LLC80005-12680005-0126-25
balsalazide disodiumBalsalazide disodium 750 mg/1CapsuleOralZydus Pharmaceuticals (USA) Inc.70710-162670710-1626-01
Balsalazide DisodiumBalsalazide disodium 750 mg/1CapsuleOralAvPAK50268-10250268-0102-13
Balsalazide DisodiumBalsalazide disodium 750 mg/1CapsuleOralHikma Pharmaceuticals USA Inc.0054-007900054-0079-28
Balsalazide DisodiumBalsalazide disodium 750 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-82051407-0820-28
Balsalazide DisodiumBalsalazide disodium 750 mg/1CapsuleOralApotex Corp.60505-257560505-2575-0060505-2575-0360505-2575-04+1 more
Balsalazide DisodiumBalsalazide disodium 750 mg/1CapsuleOralBryant Ranch Prepack72162-209572162-2095-02
Balsalazide DisodiumBalsalazide disodium 750 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-14972789-0149-69

Other NDCs under ANDA 217592

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 217592
ProductStrengthForm · routeLabelerProduct NDC
balsalazide disodiumBalsalazide disodium 750 mg/1CapsuleOralZydus Pharmaceuticals (USA) Inc.70710-1626

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