What is NDC 68382-555?

68382-555 is the product NDC for carbamazepine, Carbamazepine 100 mg/1 tablet, extended release, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals (USA) Inc., NDC labeler code 68382. 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 68382-555 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-555Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0555Add 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
68382-555-01	6838205550168382055501	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-555-01)Marketed from Mar 12, 2019
68382-555-06	6838205550668382055506	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-555-06)Marketed from Mar 12, 2019
68382-555-16	6838205551668382055516	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-555-16)Marketed from Mar 12, 2019
68382-555-30	6838205553068382055530	10 BLISTER PACK in 1 CARTON (68382-555-30) / 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 — 100 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Zydus Pharmaceuticals (USA) Inc.NDC labeler code 68382
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 68382-555_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

N468382055501 followed by a unit qualifier and the quantity

Package 68382-0555-01. 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)

About NDC 68382-555

What is NDC 68382-555?: 68382-555 is the product NDC for carbamazepine, Carbamazepine 100 mg/1 tablet, extended release, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 4 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?: Zydus Pharmaceuticals (USA) Inc., NDC labeler code 68382. 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 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 100 mg/1	Tablet, Extended releaseOral	Northstar Rx LLC	16714-063
carbamazepine	Carbamazepine 200 mg/1	Tablet, Extended releaseOral	Northstar Rx LLC	16714-064
carbamazepine	Carbamazepine 200 mg/1	Tablet, Extended releaseOral	Zydus Pharmaceuticals (USA) Inc.	68382-556
carbamazepine	Carbamazepine 400 mg/1	Tablet, Extended releaseOral	Zydus Pharmaceuticals (USA) Inc.	68382-557
carbamazepine	Carbamazepine 100 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	70771-1468
carbamazepine	Carbamazepine 200 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	70771-1469
carbamazepine	Carbamazepine 400 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	70771-1470