Asenapine NDC 42794-016

NDC codes

FDA NDC Directory

Product NDC (as listed)42794-016Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42794-0016Add 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
42794-016-08	42794001608	30 TABLET in 1 BOTTLE, PLASTIC (42794-016-08)Marketed from Dec 14, 2020
42794-016-10	42794001610	60 TABLET in 1 BOTTLE, PLASTIC (42794-016-10)Marketed from Dec 14, 2020
42794-016-22	42794001622	10 TABLET in 1 BOTTLE, PLASTIC (42794-016-22)Marketed from Dec 14, 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): Asenapine
Generic name (nonproprietary): asenapine
Active ingredients: Asenapine — 5 mg/1
Dosage form: Tablet
Route: Sublingual
Labeler: Sigmapharm Laboratories, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206107
Marketing start: Dec 14, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 42794-016_446e6925-ccb1-e388-e063-6294a90aa5deSPL ID 446e6925-ccb1-e388-e063-6294a90aa5deSPL set ID 3512687b-d1c7-45c4-8822-3a2ad53575a5RxCUI 859975, 859981UNII JKZ19V908OUPC 0342794016103, 0342794017100, 0342794017087, 0342794016226, 0342794016080, 0342794017223
Pharmacologic class: Atypical Antipsychotic

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. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N442794001608 followed by a unit qualifier and the quantity

Package 42794-0016-08. 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 Nov 25, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Asenapine sublingual tablet(s) is indicated for: Bipolar I disorder [see Clinical Studies ( 14.2 )] Adjunctive treatment to lithium or valproate in adults Asenapine is an atypical antipsychotic indicated for ( 1 ): Bipolar I disorder Adjunctive treatment to lithium or valproate in adults

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206107

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

FDA NDC Directory listings under ANDA 206107
Product	Strength	Form · route	Labeler	Product NDC
Asenapine	Asenapine 10 mg/1	TabletSublingual	Sigmapharm Laboratories, LLC	42794-017