What is NDC 46708-422?

46708-422 is the product NDC for Carbamazepine, Carbamazepine 400 mg/1 tablet, film coated, extended release, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Carbamazepine?

133 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Carbamazepine NDC 46708-422 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-422Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0422Add 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
46708-422-31	4670804223146708042231	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-422-31)Marketed from Jul 26, 2025
46708-422-91	4670804229146708042291	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-422-91)Marketed from Jul 26, 2025

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 — 400 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219939
Marketing start: Jul 26, 2025
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 46708-422_1fc170d7-db1a-486d-8c10-faa6e3da3b1eSPL ID 1fc170d7-db1a-486d-8c10-faa6e3da3b1eSPL set ID 1fc170d7-db1a-486d-8c10-faa6e3da3b1eRxCUI 199378, 402505, 402506UNII 33CM23913MUPC 0346708420314, 0346708421311, 0346708422318
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

N446708042231 followed by a unit qualifier and the quantity

Package 46708-0422-31. 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 Jul 26, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Epilepsy Carbamazepine extended-release tablet is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine extended-release tablet 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 exten…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-422

What is NDC 46708-422?: 46708-422 is the product NDC for Carbamazepine, Carbamazepine 400 mg/1 tablet, film coated, extended release, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Carbamazepine.
What is the active ingredient?: Carbamazepine.
Who is the labeler?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Carbamazepine?: 133 other product NDCs are listed under this name. See all Carbamazepine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Carbamazepine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Carbamazepine	Carbamazepine 100 mg/5mL	SuspensionOral	Precision Dose, Inc.	68094-125	68094-0125-62
Carbamazepine	Carbamazepine 100 mg/5mL	SuspensionOral	Precision Dose, Inc.	68094-225	68094-0225-62
Carbamazepine	Carbamazepine 100 mg/1	Tablet, Extended releaseOral	American Health Packaging	60687-973	60687-0973-21
Carbamazepine	Carbamazepine 200 mg/1	TabletOral	REMEDYREPACK INC.	70518-4682	70518-4682-00
Carbamazepine	Carbamazepine 100 mg/1	Tablet, ChewableOral	Coupler LLC	67046-0753	67046-0753-03
Carbamazepine	Carbamazepine 200 mg/1	TabletOral	Coupler LLC	67046-0707	67046-0707-03
Carbamazepine	Carbamazepine 100 mg/1	Capsule, Extended releaseOral	ANI Pharmaceuticals, Inc.	62559-484	62559-0484-12
Carbamazepine	Carbamazepine 200 mg/1	Capsule, Extended releaseOral	ANI Pharmaceuticals, Inc.	62559-485	62559-0485-12
Carbamazepine	Carbamazepine 300 mg/1	Capsule, Extended releaseOral	ANI Pharmaceuticals, Inc.	62559-486	62559-0486-12
Carbamazepine	Carbamazepine 200 mg/1	Tablet, Extended releaseOral	Northstar Rx LLC	72603-887	72603-0887-01

All 134 Carbamazepine NDCs

Other NDCs under ANDA 219939

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

FDA NDC Directory listings under ANDA 219939
Product	Strength	Form · route	Labeler	Product NDC
Carbamazepine	Carbamazepine 100 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-420
Carbamazepine	Carbamazepine 200 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-421
Carbamazepine	Carbamazepine 100 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-420
Carbamazepine	Carbamazepine 200 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-421
Carbamazepine	Carbamazepine 400 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-422