Carbamazepine NDC 16571-681

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-681Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0681Add 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 NDC	11-digit (billing)	Package	Copy
16571-681-01	16571068101	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-681-01)Marketed from Apr 24, 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 — 200 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Rising Pharma Holdings, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211623
Marketing start: Apr 24, 2020
Listing expires: Dec 31, 2027
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 16571-681_4444f4ee-dd67-4e98-8cd6-91bf2fb0cb0fSPL ID 4444f4ee-dd67-4e98-8cd6-91bf2fb0cb0fSPL set ID bf1590a0-68a7-45ed-817e-f97366f96ec4RxCUI 199378, 402505, 402506UNII 33CM23913MUPC 0316571681013, 0316571680016, 0316571682010
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

N416571068101 followed by a unit qualifier and the quantity

Package 16571-0681-01. 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 Dec 17, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Epilepsy Carbamazepine Extended-Release Tablet 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 Extended-Release Tablets (see…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211623

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

FDA NDC Directory listings under ANDA 211623
Product	Strength	Form · route	Labeler	Product NDC
Carbamazepine	Carbamazepine 200 mg/1	Tablet, Extended releaseOral	American Health Packaging	60687-583
Carbamazepine	Carbamazepine 400 mg/1	Tablet, Extended releaseOral	American Health Packaging	60687-594
Carbamazepine	Carbamazepine 100 mg/1	Tablet, Extended releaseOral	Rising Pharma Holdings, Inc.	16571-680
Carbamazepine	Carbamazepine 400 mg/1	Tablet, Extended releaseOral	Rising Pharma Holdings, Inc.	16571-682