NDC codes

FDA NDC Directory
Product NDC (as listed)63629-5698Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-5698Add 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
63629-5698-16362956980130 TABLET in 1 BOTTLE (63629-5698-1)Marketed from Dec 10, 2016
63629-5698-26362956980290 TABLET in 1 BOTTLE (63629-5698-2)Marketed from Dec 10, 2016
63629-5698-363629569803100 TABLET in 1 BOTTLE (63629-5698-3)Marketed from Dec 10, 2016

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Acarbose
Generic name (nonproprietary)
acarbose
Active ingredients
Acarbose — 50 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090912
Marketing start
Listing expires
Other FDA classes
alpha Glucosidase Inhibitors (Mechanism)
Identifiers
Product ID 63629-5698_539553ec-baa9-4e89-ae74-81515af2c7b8SPL ID 539553ec-baa9-4e89-ae74-81515af2c7b8SPL set ID 1ba7a072-03b0-41f2-be7a-101145bdef3aRxCUI 199149, 200132UNII T58MSI464G
Pharmacologic class
alpha-Glucosidase Inhibitor

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

N463629569801 followed by a unit qualifier and the quantity

Package 63629-5698-01. 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)

INDICATIONS AND USAGE Acarbose Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090912

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

FDA NDC Directory listings under ANDA 090912
ProductStrengthForm · routeLabelerProduct NDC
AcarboseAcarbose 50 mg/1TabletOralStrides Pharma Science Limited64380-759
AcarboseAcarbose 25 mg/1TabletOralStrides Pharma Science Limited64380-758
AcarboseAcarbose 100 mg/1TabletOralStrides Pharma Science Limited64380-760

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