Carbamazepine NDC 0904-3854

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-3854Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-3854Add 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 NDC	11-digit (billing)	Package	Copy
0904-3854-61	00904385461	100 BLISTER PACK in 1 CARTON (0904-3854-61) / 1 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Mar 22, 2010

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: Major Pharmaceuticals
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075712
Marketing start: Mar 22, 2010
Listing expires: Dec 31, 2027
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 0904-3854_8c5d19ef-ad54-44a0-afdf-632120c5446cSPL ID 8c5d19ef-ad54-44a0-afdf-632120c5446c
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

N400904385461 followed by a unit qualifier and the quantity

Package 00904-3854-61. 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 075712

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

FDA NDC Directory listings under ANDA 075712
Product	Strength	Form · route	Labeler	Product NDC
Carbamazepine	Carbamazepine 100 mg/1	Tablet, ChewableOral	Torrent Pharmaceuticals Limited	13668-271
Carbamazepine	Carbamazepine 100 mg/1	Tablet, ChewableOral	Coupler LLC	67046-0753
Carbamazepine	Carbamazepine 100 mg/1	Tablet, ChewableOral	Bryant Ranch Prepack	72162-2572
Carbamazepine	Carbamazepine 100 mg/1	Tablet, ChewableOral	American Health Packaging	60687-479