NDC codes

FDA NDC Directory
Product NDC (as listed)60687-527Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60687-0527Add 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
60687-527-21606870527216068705272130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-527-21) / 1 TABLET in 1 BLISTER PACK (60687-527-11)Marketed from Sep 11, 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)
Ursodiol
Generic name (nonproprietary)
ursodiol
Active ingredients
Ursodiol — 250 mg/1
Dosage form
Tablet
Route
Oral
Labeler
American Health PackagingNDC labeler code 60687
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211145
Marketing start
Listing expires
Other FDA classes
Bile Acids and Salts (Chemical structure)
Identifiers
Product ID 60687-527_437ecc8a-2e45-94a1-e063-6394a90acc85SPL ID 437ecc8a-2e45-94a1-e063-6394a90acc85SPL set ID a3a90d07-0dac-48fc-829a-759d9333843eRxCUI 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

N460687052721 followed by a unit qualifier and the quantity

Package 60687-0527-21. 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 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cholangitis (PBC). Ursodiol tablets 250 mg and 500 mg 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 60687-527

What is NDC 60687-527?
60687-527 is the product NDC for Ursodiol, Ursodiol 250 mg/1 tablet, listed with the FDA by American Health Packaging. 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?
American Health Packaging, NDC labeler code 60687. 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?
43 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/1CapsuleOralAurobindo Pharma Limited59651-42159651-0421-01
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

All 44 Ursodiol NDCs

Other NDCs under ANDA 211145

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

FDA NDC Directory listings under ANDA 211145
ProductStrengthForm · routeLabelerProduct NDC
UrsodiolUrsodiol 250 mg/1TabletOralZydus Pharmaceuticals (USA) Inc.70710-1127
UrsodiolUrsodiol 500 mg/1TabletOralZydus Pharmaceuticals (USA) Inc.70710-1128
UrsodiolUrsodiol 250 mg/1TabletOralZydus Lifesciences Limited70771-1407
UrsodiolUrsodiol 500 mg/1TabletOralZydus Lifesciences Limited70771-1408

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in