NDC codes

FDA NDC Directory
Product NDC (as listed)55154-1396Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-1396Add 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 NDC11-digit (billing)PackageCopy
55154-1396-0551541396005515413960010 BLISTER PACK in 1 BAG (55154-1396-0) / 1 TABLET in 1 BLISTER PACKMarketed from Sep 20, 2010

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 200 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Cardinal Health 107, LLCNDC labeler code 55154
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077272
Marketing start
Listing expires
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 55154-1396_31672dcc-b99d-46ab-b961-8afc29892e7eSPL ID 31672dcc-b99d-46ab-b961-8afc29892e7eSPL set ID 232ef732-ee6d-4ac7-8e78-c619b611fbbeRxCUI 308979UNII 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

N455154139600 followed by a unit qualifier and the quantity

Package 55154-1396-00. 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 . 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: 1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement 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, General ). Trigeminal Neur…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55154-1396

What is NDC 55154-1396?
55154-1396 is the product NDC for Carbamazepine, Carbamazepine 200 mg/1 tablet, listed with the FDA by Cardinal Health 107, LLC. It has 1 package NDC, 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?
Cardinal Health 107, LLC, NDC labeler code 55154. 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?
131 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CarbamazepineCarbamazepine 100 mg/1Tablet, Extended releaseOralAmerican Health Packaging60687-97360687-0973-21
CarbamazepineCarbamazepine 200 mg/1TabletOralREMEDYREPACK INC.70518-468270518-4682-00
CarbamazepineCarbamazepine 100 mg/1Tablet, ChewableOralCoupler LLC67046-075367046-0753-03
CarbamazepineCarbamazepine 200 mg/1TabletOralCoupler LLC67046-070767046-0707-03
CarbamazepineCarbamazepine 100 mg/1Capsule, Extended releaseOralANI Pharmaceuticals, Inc.62559-48462559-0484-12
CarbamazepineCarbamazepine 200 mg/1Capsule, Extended releaseOralANI Pharmaceuticals, Inc.62559-48562559-0485-12
CarbamazepineCarbamazepine 300 mg/1Capsule, Extended releaseOralANI Pharmaceuticals, Inc.62559-48662559-0486-12
CarbamazepineCarbamazepine 100 mg/1Tablet, Extended releaseOralNorthstar Rx LLC72603-88672603-0886-01
CarbamazepineCarbamazepine 200 mg/1Tablet, Extended releaseOralNorthstar Rx LLC72603-88772603-0887-01
CarbamazepineCarbamazepine 400 mg/1Tablet, Extended releaseOralNorthstar Rx LLC72603-88872603-0888-01

All 132 Carbamazepine NDCs

Other NDCs under ANDA 077272

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

FDA NDC Directory listings under ANDA 077272
ProductStrengthForm · routeLabelerProduct NDC
CarbamazepineCarbamazepine 200 mg/1TabletOralMajor Pharmaceuticals0904-6172
CarbamazepineCarbamazepine 200 mg/1TabletOralTorrent Pharmaceuticals Limited13668-268

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