Prescription drug · ANDA

Carbamazepine ER NDC 62135-927

Carbamazepine 100 mg/1 · Tablet, Extended release · Oral · Chartwell RX, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)62135-927Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0927Add 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
62135-927-606213509276060 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-927-60)Marketed from Nov 6, 2024

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 ER
Generic name (nonproprietary)
carbamazepine er
Active ingredients
Carbamazepine — 100 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215591
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 62135-927_458c15a3-d257-681b-e063-6294a90a282aSPL ID 458c15a3-d257-681b-e063-6294a90a282aSPL set ID bf2bff52-d1ae-4b81-951c-7d39d3c5058fRxCUI 199378, 402505, 402506UNII 33CM23913MUPC 0362135930608, 0362135928605, 0362135927608
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

N462135092760 followed by a unit qualifier and the quantity

Package 62135-0927-60. 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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215591

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

FDA NDC Directory listings under ANDA 215591
ProductStrengthForm · routeLabelerProduct NDC
Carbamazepine ERcarbamazepineCarbamazepine 400 mg/1Tablet, Extended releaseOralBostal LLC35561-357
Carbamazepine ERCarbamazepine 200 mg/1Tablet, Extended releaseOralChartwell RX, LLC62135-928
Carbamazepine ERCarbamazepine 400 mg/1Tablet, Extended releaseOralChartwell RX, LLC62135-930
Carbamazepine ERcarbamazepineCarbamazepine 200 mg/1Tablet, Extended releaseOralBostal LLC35561-356
Carbamazepine ERcarbamazepineCarbamazepine 100 mg/1Tablet, Extended releaseOralBostal LLC35561-355

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Carbamazepine ER NDC 62135-927 | Med-Code