NDC codes

FDA NDC Directory
Product NDC (as listed)75834-220Labeler and product segments. Claims need a package NDC.
Product NDC at billing width75834-0220Add 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
75834-220-0075834022000758340220001000 TABLET in 1 BOTTLE (75834-220-00)Marketed from Apr 21, 2020
75834-220-017583402200175834022001100 TABLET in 1 BOTTLE (75834-220-01)Marketed from Apr 21, 2020

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
Route
Oral
Labeler
NIVAGEN PHARMACEUTICALS, INC.NDC labeler code 75834
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207798
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 75834-220_5cad93e2-6a7b-0244-e063-6294a90a5d9fSPL ID 5cad93e2-6a7b-0244-e063-6294a90a5d9f
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

N475834022000 followed by a unit qualifier and the quantity

Package 75834-0220-00. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 75834-220

What is NDC 75834-220?
75834-220 is the product NDC for Carbamazepine, Carbamazepine 100 mg/1 tablet, listed with the FDA by NIVAGEN PHARMACEUTICALS, INC.. It has 2 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?
NIVAGEN PHARMACEUTICALS, INC., NDC labeler code 75834. 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 207798

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

FDA NDC Directory listings under ANDA 207798
ProductStrengthForm · routeLabelerProduct NDC
CarbamazepineCarbamazepine 200 mg/1TabletOralA-S Medication Solutions50090-5740
CarbamazepineCarbamazepine 200 mg/1TabletOralUmedica Laboratories USA Inc.60290-008
CarbamazepineCarbamazepine 100 mg/1TabletOralUmedica Laboratories USA Inc.60290-034
CarbamazepineCarbamazepine 200 mg/1TabletOralCoupler LLC67046-0707
CarbamazepineCarbamazepine 200 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-7825
CarbamazepineCarbamazepine 200 mg/1TabletOralREMEDYREPACK INC.70518-2841
CarbamazepineCarbamazepine 200 mg/1TabletOralBryant Ranch Prepack71335-1730
CarbamazepineCarbamazepine 200 mg/1TabletOraldirect rx72189-157
CarbamazepineCarbamazepine 200 mg/1TabletOralNIVAGEN PHARMACEUTICALS, INC.75834-221

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