What is NDC 80005-126?

80005-126 is the product NDC for balsalazide disodium, Balsalazide disodium 750 mg/1 capsule, listed with the FDA by Carnegie Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Carnegie Pharmaceuticals, LLC, NDC labeler code 80005. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

balsalazide disodium NDC 80005-126 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80005-126Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80005-0126Add 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 NDC	11-digit (billing)	Package	Copy
80005-126-25	80005012625	280 CAPSULE in 1 BOTTLE (80005-126-25)Marketed from Jun 30, 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): balsalazide disodium
Generic name (nonproprietary): balsalazide disodium
Active ingredients: Balsalazide disodium — 750 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Carnegie Pharmaceuticals, LLCNDC labeler code 80005
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219422
Marketing start: Jun 30, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 80005-126_8bfef633-a30b-4aac-b768-cce1c8e151c4SPL ID 8bfef633-a30b-4aac-b768-cce1c8e151c4SPL set ID 620f86cb-b6a2-4af8-a642-925dd8a1c5feRxCUI 885857UNII 1XL6BJI034UPC 0380005126258
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

N480005012625 followed by a unit qualifier and the quantity

Package 80005-0126-25. 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 Apr 15, 2025.

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 5-17 years) and 12 weeks in adults have not been established. ( 1 )…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80005-126

What is NDC 80005-126?: 80005-126 is the product NDC for balsalazide disodium, Balsalazide disodium 750 mg/1 capsule, listed with the FDA by Carnegie Pharmaceuticals, LLC. 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?: Carnegie Pharmaceuticals, LLC, NDC labeler code 80005. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
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	Zydus Lifesciences Limited	70771-1841	70771-1841-01
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