Carbamazepine NDC 69452-312

NDC codes

FDA NDC Directory

Product NDC (as listed)69452-312Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69452-0312Add 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
69452-312-20	69452031220	100 TABLET in 1 BOTTLE (69452-312-20)Marketed from Mar 15, 2024
69452-312-32	69452031232	1000 TABLET in 1 BOTTLE (69452-312-32)Marketed from Jul 15, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 200 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bionpharma Inc.,
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218221
Marketing start: Mar 15, 2024
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 69452-312_556a28f6-3162-38b6-e063-6294a90a0908SPL ID 556a28f6-3162-38b6-e063-6294a90a0908SPL set ID 138d9ed1-2f8e-d19d-e063-6394a90a695dRxCUI 308979UNII 33CM23913M
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

N469452031220 followed by a unit qualifier and the quantity

Package 69452-0312-20. 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 Jun 29, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Epilepsy Carbamazepine tablets are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. Generalized tonic-clonic seizures (grand mal). Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine ( see PRECAUTIONS , General ). Trigeminal Ne…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 218221

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

FDA NDC Directory listings under ANDA 218221
Product	Strength	Form · route	Labeler	Product NDC
Carbamazepine	Carbamazepine 200 mg/1	TabletOral	REMEDYREPACK INC.	70518-4167
Carbamazepine	Carbamazepine 200 mg/1	TabletOral	AvPAK	50268-160