Carbamazepine NDC 62135-802

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-802Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0802Add 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
62135-802-24	62135080224	2 TRAY in 1 BOX (62135-802-24) / 10 PACKAGE in 1 TRAY / 5 mL in 1 PACKAGE (62135-802-45)Marketed from May 28, 2024
62135-802-53	62135080253	450 mL in 1 BOTTLE (62135-802-53)Marketed from Dec 1, 2023

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 — 100 mg/5mL
Dosage form: Suspension
Route: Oral
Labeler: Chartwell RX, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075714
Marketing start: Jun 5, 2002
Listing expires: Dec 31, 2026
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 62135-802_199bb366-8124-4f1f-e063-6294a90a231bSPL ID 199bb366-8124-4f1f-e063-6294a90a231bSPL set ID 8d5ace90-983b-48c4-baf1-b44f6af146deRxCUI 308976UNII 33CM23913MUPC 0362135802530
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

N462135080224 followed by a unit qualifier and the quantity

Package 62135-0802-24. 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 May 29, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Epilepsy Carbamazepine is 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 Neuralgia Car…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075714

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

FDA NDC Directory listings under ANDA 075714
Product	Strength	Form · route	Labeler	Product NDC
Carbamazepine	Carbamazepine 200 mg/10mL	SuspensionOral	Chartwell RX, LLC	62135-867
Carbamazepine	Carbamazepine 100 mg/5mL	SuspensionOral	Chartwell Governmental & Specialty RX, LLC.	68999-802
Carbamazepine	Carbamazepine 200 mg/10mL	SuspensionOral	Chartwell Governmental & Specialty RX, LLC.	68999-867