NDC codes

FDA NDC Directory
Product NDC (as listed)72789-149Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72789-0149Add 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
72789-149-6972789014969280 CAPSULE in 1 BOTTLE, PLASTIC (72789-149-69)Marketed from Dec 2, 2020

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
PD-Rx Pharmaceuticals, Inc.NDC labeler code 72789
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077806
Marketing start
Listing expires
Other FDA classes
Aminosalicylic Acids (Chemical structure)
Identifiers
Product ID 72789-149_40a76214-2087-acc4-e063-6394a90ae00eSPL ID 40a76214-2087-acc4-e063-6394a90ae00eSPL set ID b3ecc533-dd55-4a2f-84c4-ecd454aae766RxCUI 885857UNII 1XL6BJI034UPC 0372789149691
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

N472789014969 followed by a unit qualifier and the quantity

Package 72789-0149-69. 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 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 72789-149

What is NDC 72789-149?
72789-149 is the product NDC for Balsalazide Disodium, Balsalazide disodium 750 mg/1 capsule, listed with the FDA by PD-Rx Pharmaceuticals, 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?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 72789. 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/1CapsuleOralZydus Lifesciences Limited70771-184170771-1841-01
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

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
ProductStrengthForm · routeLabelerProduct NDC
Balsalazide DisodiumBalsalazide disodium 750 mg/1CapsuleOralHikma Pharmaceuticals USA Inc.0054-0079
Balsalazide DisodiumBalsalazide disodium 750 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-820

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