NDC codes

FDA NDC Directory
Product NDC (as listed)0615-8125Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00615-8125Add 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
0615-8125-39006158125390061581253930 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8125-39)Marketed from Jun 6, 2019

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)
Carbamazepine
Generic name (nonproprietary)
carbamazepine
Active ingredients
Carbamazepine — 100 mg/1
Dosage form
Tablet, Chewable
Route
Oral
Labeler
NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075687
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 1A2 Inducers (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2C19 Inducers (Mechanism)Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 0615-8125_b49f7644-5e05-4003-a1a8-d1ab9d7c6228SPL ID b49f7644-5e05-4003-a1a8-d1ab9d7c6228
Pharmacologic class
Mood Stabilizer

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

N400615812539 followed by a unit qualifier and the quantity

Package 00615-8125-39. 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 0615-8125

What is NDC 0615-8125?
0615-8125 is the product NDC for Carbamazepine, Carbamazepine 100 mg/1 tablet, chewable, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Carbamazepine.
What is the active ingredient?
Carbamazepine.
Who is the labeler?
NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Carbamazepine?
133 other product NDCs are listed under this name. See all Carbamazepine 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 Carbamazepine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CarbamazepineCarbamazepine 100 mg/5mLSuspensionOralPrecision Dose, Inc.68094-12568094-0125-62
CarbamazepineCarbamazepine 100 mg/5mLSuspensionOralPrecision Dose, Inc.68094-22568094-0225-62
CarbamazepineCarbamazepine 100 mg/1Tablet, Extended releaseOralAmerican Health Packaging60687-97360687-0973-21
CarbamazepineCarbamazepine 200 mg/1TabletOralREMEDYREPACK INC.70518-468270518-4682-00
CarbamazepineCarbamazepine 100 mg/1Tablet, ChewableOralCoupler LLC67046-075367046-0753-03
CarbamazepineCarbamazepine 200 mg/1TabletOralCoupler LLC67046-070767046-0707-03
CarbamazepineCarbamazepine 100 mg/1Capsule, Extended releaseOralANI Pharmaceuticals, Inc.62559-48462559-0484-12
CarbamazepineCarbamazepine 200 mg/1Capsule, Extended releaseOralANI Pharmaceuticals, Inc.62559-48562559-0485-12
CarbamazepineCarbamazepine 300 mg/1Capsule, Extended releaseOralANI Pharmaceuticals, Inc.62559-48662559-0486-12
CarbamazepineCarbamazepine 200 mg/1Tablet, Extended releaseOralNorthstar Rx LLC72603-88772603-0887-01

All 134 Carbamazepine NDCs

Other NDCs under ANDA 075687

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

FDA NDC Directory listings under ANDA 075687
ProductStrengthForm · routeLabelerProduct NDC
CarbamazepineCarbamazepine 100 mg/1Tablet, ChewableOralSun Pharmaceutical Industries, Inc.51672-4041
CarbamazepineCarbamazepine 200 mg/1Tablet, ChewableOralSun Pharmaceutical Industries, Inc.51672-4050
CarbamazepineCarbamazepine 100 mg/1Tablet, ChewableOralGolden State Medical Supply, Inc.60429-934
CarbamazepineCarbamazepine 100 mg/1Tablet, ChewableOralREMEDYREPACK INC.70518-1433
CarbamazepineCarbamazepine 100 mg/1Tablet, ChewableOralREMEDYREPACK INC.70518-2426

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