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
0615-8125-390061581253930 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
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.

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, ChewableOralREMEDYREPACK INC.70518-2426
CarbamazepineCarbamazepine 100 mg/1Tablet, ChewableOralSun Pharmaceutical Industries, Inc.51672-4041
CarbamazepineCarbamazepine 100 mg/1Tablet, ChewableOralGolden State Medical Supply, Inc.60429-934
CarbamazepineCarbamazepine 100 mg/1Tablet, ChewableOralREMEDYREPACK INC.70518-1433
CarbamazepineCarbamazepine 200 mg/1Tablet, ChewableOralSun Pharmaceutical Industries, Inc.51672-4050

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