Carbamazepine NDC 62559-486

NDC codes

FDA NDC Directory

Product NDC (as listed)62559-486Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62559-0486Add 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
62559-486-12	62559048612	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-486-12)Marketed from Apr 13, 2026

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 — 300 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: ANI Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076697
Marketing start: Apr 13, 2026
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 62559-486_c1876184-0323-4b06-b459-603b40c0c002SPL ID c1876184-0323-4b06-b459-603b40c0c002SPL set ID c1876184-0323-4b06-b459-603b40c0c002RxCUI 200131, 200133, 388311UNII 33CM23913MUPC 0362559485128, 0362559484121, 0362559486125
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

N462559048612 followed by a unit qualifier and the quantity

Package 62559-0486-12. 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 Apr 13, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Epilepsy Carbamazepine extended-release capsules 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: 1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvements than those with other types. 2. Generalized tonic-clonic seizures (grand mal). 3. 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076697

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

FDA NDC Directory listings under ANDA 076697
Product	Strength	Form · route	Labeler	Product NDC
Carbamazepine	Carbamazepine 100 mg/1	Capsule, Extended releaseOral	ANI Pharmaceuticals, Inc.	62559-484
Carbamazepine	Carbamazepine 100 mg/1	Capsule, Extended releaseOral	Coupler LLC	67046-1558
Carbamazepine	Carbamazepine 200 mg/1	Capsule, Extended releaseOral	ANI Pharmaceuticals, Inc.	62559-485
Carbamazepine	Carbamazepine 200 mg/1	Capsule, Extended releaseOral	Coupler LLC	67046-1559
Carbamazepine	Carbamazepine 300 mg/1	Capsule, Extended releaseOral	Coupler LLC	67046-1455