Prescription drug · ANDA

Carbamazepine NDC 50268-171

Carbamazepine 200 mg/1 · Capsule, Extended release · Oral · AvPAK

NDC codes

FDA NDC Directory
Product NDC (as listed)50268-171Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50268-0171Add 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
50268-171-13502680171135026801711330 BLISTER PACK in 1 BOX (50268-171-13) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-171-11)Marketed from Oct 19, 2021

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 — 200 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Labeler
AvPAKNDC labeler code 50268
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078986
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 50268-171_47e2efaa-df8e-5401-e063-6394a90aae6cSPL ID 47e2efaa-df8e-5401-e063-6394a90aae6cSPL set ID ceb84aa4-2041-6e6e-e053-2995a90a0f24RxCUI 200131, 200133, 388311UNII 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

N450268017113 followed by a unit qualifier and the quantity

Package 50268-0171-13. 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 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: Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvements 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 (see PRECAUTIONS, General…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50268-171

What is NDC 50268-171?
50268-171 is the product NDC for Carbamazepine, Carbamazepine 200 mg/1 capsule, extended release, listed with the FDA by AvPAK. 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?
AvPAK, NDC labeler code 50268. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CarbamazepineCarbamazepine 100 mg/5mLSuspensionOralPrecision Dose, Inc.68094-12568094-0125-62
CarbamazepineCarbamazepine 100 mg/5mLSuspensionOralPrecision Dose, Inc.68094-22568094-0225-62
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 200 mg/1Tablet, Extended releaseOralNorthstar Rx LLC72603-88772603-0887-01

All 134 Carbamazepine NDCs

Other NDCs under ANDA 078986

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

FDA NDC Directory listings under ANDA 078986
ProductStrengthForm · routeLabelerProduct NDC
CarbamazepineCarbamazepine 200 mg/1Capsule, Extended releaseOralMajor Pharmaceuticals0904-6885
CarbamazepineCarbamazepine 100 mg/1Capsule, Extended releaseOralAvPAK50268-170
CarbamazepineCarbamazepine 300 mg/1Capsule, Extended releaseOralAvPAK50268-172
CarbamazepineCarbamazepine 100 mg/1Capsule, Extended releaseOralApotex Corp.60505-2805
CarbamazepineCarbamazepine 200 mg/1Capsule, Extended releaseOralApotex Corp.60505-2806
CarbamazepineCarbamazepine 300 mg/1Capsule, Extended releaseOralApotex Corp.60505-2807
CarbamazepineCarbamazepine 300 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-4492
CarbamazepineCarbamazepine 200 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-2706
CarbamazepineCarbamazepine 300 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-2707
CarbamazepineCarbamazepine 100 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-2921
CarbamazepineCarbamazepine 300 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-3001
CarbamazepineCarbamazepine 200 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-3002
CarbamazepineCarbamazepine 100 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-3077
CarbamazepineCarbamazepine 300 mg/1Capsule, Extended releaseOralBryant Ranch Prepack72162-1715

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