What is NDC 0054-0079?

0054-0079 is the product NDC for Balsalazide Disodium, Balsalazide disodium 750 mg/1 capsule, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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 0054-0079 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0079Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0079Add 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
0054-0079-28	00054007928	280 CAPSULE in 1 BOTTLE (0054-0079-28)Marketed from Dec 28, 2007

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077806
Marketing start: Dec 28, 2007
Listing expires: Dec 31, 2026
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 0054-0079_6f5a92d7-1828-44ea-8265-0ed1b3bef16cSPL ID 6f5a92d7-1828-44ea-8265-0ed1b3bef16cSPL set ID a0498308-14b2-4456-8e13-795f6fc8ea30RxCUI 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

N400054007928 followed by a unit qualifier and the quantity

Package 00054-0079-28. 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 Feb 22, 2024.

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 beyond 8 weeks in children (ages 5 to 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 0054-0079

What is NDC 0054-0079?: 0054-0079 is the product NDC for Balsalazide Disodium, Balsalazide disodium 750 mg/1 capsule, listed with the FDA by Hikma Pharmaceuticals USA Inc.. 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?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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	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	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	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 077806

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

FDA NDC Directory listings under ANDA 077806
Product	Strength	Form · route	Labeler	Product NDC
Balsalazide Disodium	Balsalazide disodium 750 mg/1	CapsuleOral	Golden State Medical Supply, Inc.	51407-820
Balsalazide Disodium	Balsalazide disodium 750 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	72789-149