NDC codes

FDA NDC Directory
Product NDC (as listed)0054-0140Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00054-0140Add 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
0054-0140-2500054014025100 TABLET in 1 BOTTLE (0054-0140-25)Marketed from May 7, 2008

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)
Acarbose
Generic name (nonproprietary)
acarbose
Active ingredients
Acarbose — 25 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078470
Marketing start
Listing expires
Other FDA classes
alpha Glucosidase Inhibitors (Mechanism)
Identifiers
Product ID 0054-0140_2d7f6918-65c3-4db3-b775-b74e1e637ceaSPL ID 2d7f6918-65c3-4db3-b775-b74e1e637ceaSPL set ID 352dd336-d3f9-4ac5-a000-91d3aef7aca3RxCUI 199149, 199150, 200132UNII T58MSI464GUPC 0300540140250
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

N400054014025 followed by a unit qualifier and the quantity

Package 00054-0140-25. 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)

About NDC 0054-0140

What is NDC 0054-0140?
0054-0140 is the product NDC for Acarbose, Acarbose 25 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Acarbose.
What is the active ingredient?
Acarbose.
Who is the labeler?
Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Acarbose?
16 other product NDCs are listed under this name. See all Acarbose 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 Acarbose NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AcarboseAcarbose 25 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-14723155-0147-0123155-0147-0523155-0147-10
AcarboseAcarbose 50 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-14823155-0148-0123155-0148-0523155-0148-10
AcarboseAcarbose 100 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-14923155-0149-0123155-0149-0523155-0149-10
AcarboseAcarbose 25 mg/1TabletOralChartwell RX, LLC62135-45362135-0453-90
AcarboseAcarbose 50 mg/1TabletOralChartwell RX, LLC62135-45462135-0454-90
AcarboseAcarbose 100 mg/1TabletOralChartwell RX, LLC62135-45562135-0455-90
AcarboseAcarbose 50 mg/1TabletOralBryant Ranch Prepack71335-972571335-9725-0171335-9725-0271335-9725-03
AcarboseAcarbose 50 mg/1TabletOralBryant Ranch Prepack63629-569863629-5698-0163629-5698-0263629-5698-03
AcarboseAcarbose 50 mg/1TabletOralStrides Pharma Science Limited64380-75964380-0759-06
AcarboseAcarbose 100 mg/1TabletOralStrides Pharma Science Limited64380-76064380-0760-06

All 17 Acarbose NDCs

Other NDCs under ANDA 078470

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

FDA NDC Directory listings under ANDA 078470
ProductStrengthForm · routeLabelerProduct NDC
AcarboseAcarbose 50 mg/1TabletOralHikma Pharmaceuticals USA Inc.0054-0141
AcarboseAcarbose 100 mg/1TabletOralHikma Pharmaceuticals USA Inc.0054-0142
AcarboseAcarbose 25 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-131
AcarboseAcarbose 50 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-132
AcarboseAcarbose 100 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-133

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