NDC codes

FDA NDC Directory
Product NDC (as listed)13668-285Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13668-0285Add 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
13668-285-011366802850113668028501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-285-01)Marketed from Sep 10, 2025
13668-285-051366802850513668028505500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-285-05)Marketed from Sep 10, 2025
13668-285-2213668028522136680285228 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (13668-285-22)Marketed from Sep 10, 2025
13668-285-23136680285231366802852380 TABLET, EXTENDED RELEASE in 1 CARTON (13668-285-23)Marketed from Sep 10, 2025
13668-285-30136680285301366802853030 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-285-30)Marketed from Sep 10, 2025
13668-285-60136680285601366802856060 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-285-60)Marketed from Sep 10, 2025

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
Torrent Pharmaceuticals LimitedNDC labeler code 13668
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212524
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 13668-285_b92a6e26-d2e9-426f-8a44-2403c074c080SPL ID b92a6e26-d2e9-426f-8a44-2403c074c080SPL set ID 7c4860c1-daba-4e0f-97fd-d30cbc8603a2RxCUI 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

N413668028501 followed by a unit qualifier and the quantity

Package 13668-0285-01. 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 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: 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 (see PRECAUTIONS, General). Trigeminal Neuralgia Carb…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 13668-285

What is NDC 13668-285?
13668-285 is the product NDC for Carbamazepine, Carbamazepine 200 mg/1 tablet, extended release, listed with the FDA by Torrent Pharmaceuticals Limited. It has 6 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?
Torrent Pharmaceuticals Limited, NDC labeler code 13668. 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 212524

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

FDA NDC Directory listings under ANDA 212524
ProductStrengthForm · routeLabelerProduct NDC
CarbamazepineCarbamazepine 100 mg/1Tablet, Extended releaseOralTorrent Pharmaceuticals Limited13668-284
CarbamazepineCarbamazepine 400 mg/1Tablet, Extended releaseOralTorrent Pharmaceuticals Limited13668-286

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