carbamazepine NDC 68382-557

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-557Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0557Add 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
68382-557-01	68382055701	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-557-01)Marketed from Mar 12, 2019
68382-557-06	68382055706	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-557-06)Marketed from Mar 12, 2019
68382-557-16	68382055716	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-557-16)Marketed from Mar 12, 2019
68382-557-30	68382055730	10 BLISTER PACK in 1 CARTON (68382-557-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Mar 12, 2019

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, Extended release
Route: Oral
Labeler: Zydus Pharmaceuticals (USA) Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205571
Marketing start: Mar 12, 2019
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 68382-557_ce978022-a6e7-4be2-8794-18ecc1fd6725SPL ID ce978022-a6e7-4be2-8794-18ecc1fd6725SPL set ID c5e4a25a-0137-4327-96f5-15735891ad5cRxCUI 199378, 402505, 402506UNII 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

N468382055701 followed by a unit qualifier and the quantity

Package 68382-0557-01. 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 Aug 4, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Epilepsy Carbamazepine extended-release tablets are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine extended-release tablets 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 ex…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205571

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

FDA NDC Directory listings under ANDA 205571
Product	Strength	Form · route	Labeler	Product NDC
carbamazepine	Carbamazepine 200 mg/1	Tablet, Extended releaseOral	Northstar Rx LLC	16714-064
carbamazepine	Carbamazepine 100 mg/1	Tablet, Extended releaseOral	Northstar Rx LLC	16714-063
carbamazepine	Carbamazepine 100 mg/1	Tablet, Extended releaseOral	Zydus Pharmaceuticals (USA) Inc.	68382-555
carbamazepine	Carbamazepine 200 mg/1	Tablet, Extended releaseOral	Zydus Pharmaceuticals (USA) Inc.	68382-556
carbamazepine	Carbamazepine 200 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	70771-1469
carbamazepine	Carbamazepine 100 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	70771-1468
carbamazepine	Carbamazepine 400 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	70771-1470