Prescription drug · ANDA

Carbamazepine NDC 51672-4124

Carbamazepine 200 mg/1 · Tablet, Extended release · Oral · Sun Pharmaceutical Industries, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)51672-4124Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51672-4124Add 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
51672-4124-15167241240151672412401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4124-1)Marketed from Mar 31, 2009
51672-4124-351672412403516724124031000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4124-3)Marketed from Mar 31, 2009
51672-4124-6516724124065167241240630 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4124-6)Marketed from Mar 31, 2009

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, Extended release
Route
Oral
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078115
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 51672-4124_5a4a48b3-c961-591d-e063-6394a90ab81dSPL ID 5a4a48b3-c961-591d-e063-6394a90ab81d
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

N451672412401 followed by a unit qualifier and the quantity

Package 51672-4124-01. 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

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

About NDC 51672-4124

What is NDC 51672-4124?
51672-4124 is the product NDC for Carbamazepine, Carbamazepine 200 mg/1 tablet, extended release, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 3 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?
Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. 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 078115

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

FDA NDC Directory listings under ANDA 078115
ProductStrengthForm · routeLabelerProduct NDC
CarbamazepineCarbamazepine 100 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.51407-895
CarbamazepineCarbamazepine 200 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.51407-896
CarbamazepineCarbamazepine 400 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.51407-897
CarbamazepineCarbamazepine 100 mg/1Tablet, Extended releaseOralSun Pharmaceutical Industries, Inc.51672-4123
CarbamazepineCarbamazepine 400 mg/1Tablet, Extended releaseOralSun Pharmaceutical Industries, Inc.51672-4125
CarbamazepineCarbamazepine 400 mg/1Tablet, Extended releaseOralCoupler, LLC67046-1534

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