NDC codes

FDA NDC Directory
Product NDC (as listed)16714-064Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0064Add 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
16714-064-011671400640116714006401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-064-01)Marketed from Feb 1, 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
Tablet, Extended release
Route
Oral
Labeler
Northstar Rx LLCNDC labeler code 16714
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205571
Marketing start
Marketing end
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 16714-064_44af53b1-b342-4c03-9c44-93ee53482796SPL ID 44af53b1-b342-4c03-9c44-93ee53482796SPL set ID c91a5a1b-5481-445b-86e8-f10109ac3937RxCUI 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

N416714006401 followed by a unit qualifier and the quantity

Package 16714-0064-01. 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 . 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 16714-064

What is NDC 16714-064?
16714-064 is the product NDC for carbamazepine, Carbamazepine 200 mg/1 tablet, extended release, listed with the FDA by Northstar Rx 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?
Northstar Rx LLC, NDC labeler code 16714. 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 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
ProductStrengthForm · routeLabelerProduct NDC
carbamazepineCarbamazepine 100 mg/1Tablet, Extended releaseOralNorthstar Rx LLC16714-063
carbamazepineCarbamazepine 100 mg/1Tablet, Extended releaseOralZydus Pharmaceuticals (USA) Inc.68382-555
carbamazepineCarbamazepine 200 mg/1Tablet, Extended releaseOralZydus Pharmaceuticals (USA) Inc.68382-556
carbamazepineCarbamazepine 400 mg/1Tablet, Extended releaseOralZydus Pharmaceuticals (USA) Inc.68382-557
carbamazepineCarbamazepine 100 mg/1Tablet, Extended releaseOralZydus Lifesciences Limited70771-1468
carbamazepineCarbamazepine 200 mg/1Tablet, Extended releaseOralZydus Lifesciences Limited70771-1469
carbamazepineCarbamazepine 400 mg/1Tablet, Extended releaseOralZydus Lifesciences Limited70771-1470

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