Unfinished product

This listing is a drug for further processing, not a finished drug product dispensed or administered to patients. It is not normally billed.

NDC codes

FDA NDC Directory
Product NDC (as listed)59651-421Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0421Add 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
59651-421-11596510421111000 CAPSULE in 1 BAG (59651-421-11)Marketed from 28-NOV-22

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

Generic name (nonproprietary)
ursodiol
Active ingredients
Ursodiol — 300 mg/1
Dosage form
Capsule
Labeler
Aurobindo Pharma LimitedNDC labeler code 59651
Product type
Drug for further processing
Marketing category
Drug for further processing
Marketing start
Listing expires
Identifiers
Product ID 59651-421_3fa7ade3-c0ff-4b02-9284-79f9fb06bd1fSPL ID 3fa7ade3-c0ff-4b02-9284-79f9fb06bd1f

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N459651042111 followed by a unit qualifier and the quantity

Package 59651-0421-11. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 59651-421

What is NDC 59651-421?
59651-421 is the product NDC for Ursodiol, Ursodiol 300 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. 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?
Aurobindo Pharma Limited, NDC labeler code 59651. 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

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