NDC codes

FDA NDC Directory
Product NDC (as listed)0904-6890Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-6890Add 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
0904-6890-040090468900430 BLISTER PACK in 1 CARTON (0904-6890-04) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 1, 2013

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)
Ursodiol
Generic name (nonproprietary)
ursodiol
Active ingredients
Ursodiol — 250 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Major PharmaceuticalsNDC labeler code 0904
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202540
Marketing start
Listing expires
Other FDA classes
Bile Acids and Salts (Chemical structure)
Identifiers
Product ID 0904-6890_322b164b-3399-4863-abd6-489173169b7cSPL ID 322b164b-3399-4863-abd6-489173169b7cSPL set ID e1f6abfd-2158-4824-b53d-717fbe6de3f9RxCUI 858751UNII 724L30Y2QR
Pharmacologic class
Bile Acid

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

N400904689004 followed by a unit qualifier and the quantity

Package 00904-6890-04. 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)

Ursodiol tablets are indicated for the treatment of patients with primary biliary cholangitis (PBC). Ursodiol tablets are bile acids indicated for the treatment of patients with primary biliary cholangitis. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0904-6890

What is NDC 0904-6890?
0904-6890 is the product NDC for Ursodiol, Ursodiol 250 mg/1 tablet, film coated, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ursodiol.
What is the active ingredient?
Ursodiol.
Who is the labeler?
Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ursodiol?
41 other product NDCs are listed under this name. See all Ursodiol 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 Ursodiol NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
UrsodiolUrsodiol 300 mg/1CapsuleOralAvPAK50268-86450268-0864-13
UrsodiolUrsodiol 300 mg/1CapsuleOralNorthStar Rx LLC72603-61372603-0613-01
UrsodiolUrsodiol 250 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-263355154-2633-00
UrsodiolUrsodiol 500 mg/1Tablet, Film coatedOralAvKARE42291-93142291-0931-01
UrsodiolUrsodiol 300 mg/1CapsuleOralAvKARE42291-92342291-0923-01
UrsodiolUrsodiol 300 mg/1CapsuleOralBryant Ranch Prepack72162-261972162-2619-01
UrsodiolUrsodiol 300 mg/1CapsuleOralPuraCap Laboratories, LLC24658-99924658-0999-10
UrsodiolUrsodiol 300 mg/1CapsuleOralStrides Pharma Science Limited64380-84464380-0844-0464380-0844-0664380-0844-07
UrsodiolUrsodiol 300 mg/1CapsuleOralLaurus Labs Limited42385-94642385-0946-01
UrsodiolUrsodiol 300 mg/1CapsuleOralAvPAK50268-79750268-0797-15

All 42 Ursodiol NDCs

Other NDCs under ANDA 202540

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

FDA NDC Directory listings under ANDA 202540
ProductStrengthForm · routeLabelerProduct NDC
UrsodiolUrsodiol 250 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-2633
UrsodiolUrsodiol 500 mg/1Tablet, Film coatedOralAvKARE42291-931
UrsodiolUrsodiol 500 mg/1Tablet, Film coatedOralPar Health USA, LLC49884-413
UrsodiolUrsodiol 250 mg/1Tablet, Film coatedOralPar Health USA, LLC49884-412
UrsodiolUrsodiol 250 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-2286
UrsodiolUrsodiol 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-2287
UrsodiolUrsodiol 250 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1500
UrsodiolUrsodiol 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1501

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