What is NDC 81968-045?

81968-045 is the product NDC for Auvelity, Dextromethorphan hydrobromide 45 mg/1; Bupropion hydrochloride 105 mg/1 tablet, multilayer, extended release, listed with the FDA by Axsome Therapeutics, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Auvelity (Dextromethorphan hydrobromide, bupropion hydrochloride).

What is the active ingredient?

Dextromethorphan hydrobromide, Bupropion hydrochloride.

Axsome Therapeutics, Inc., NDC labeler code 81968. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Auvelity?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Auvelity NDC 81968-045 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)81968-045Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81968-0045Add 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
81968-045-14	81968004514	1 BOTTLE in 1 CARTON (81968-045-14) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLEMarketed from Sep 18, 2024 · Sample package
81968-045-30	81968004530	30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-30)Marketed from Aug 18, 2022
81968-045-31	81968004531	1 BOTTLE in 1 CARTON (81968-045-31) / 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLEMarketed from May 10, 2024 · Sample package
81968-045-60	81968004560	60 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-60)Marketed from Jun 28, 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): Auvelity
Generic name (nonproprietary): dextromethorphan hydrobromide, bupropion hydrochloride
Active ingredients: Dextromethorphan hydrobromide — 45 mg/1Bupropion hydrochloride — 105 mg/1
Dosage form: Tablet, Multilayer, Extended release
Route: Oral
Labeler: Axsome Therapeutics, Inc.NDC labeler code 81968
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 215430
Marketing start: Aug 18, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Dopamine Uptake Inhibitors (Mechanism)Increased Dopamine Activity (Physiologic effect)Increased Norepinephrine Activity (Physiologic effect)Norepinephrine Uptake Inhibitors (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 81968-045_948d108e-f3a6-4e83-a4f2-ff8edf184e1bSPL ID 948d108e-f3a6-4e83-a4f2-ff8edf184e1bSPL set ID dcefda7c-9a68-278e-e053-2995a90aec79RxCUI 2611260, 2611266, 2741701, 2741703, 2744512, 2744513, 2744514, 2744515UNII ZG7E5POY8O, 9D2RTI9KYHUPC 0381968045600, 0381968030224, 0381968045310, 0381968045143
Pharmacologic class: Aminoketone; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist

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

N481968004514 followed by a unit qualifier and the quantity

Package 81968-0045-14. 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 Aug 17, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

AUVELITY is a combination of dextromethorphan, an uncompetitive N -methyl D -aspartate (NMDA) receptor antagonist and sigma-1 receptor agonist, and bupropion, an aminoketone and CYP450 2D6 inhibitor, indicated for the treatment of major depressive disorder (MDD) in adults ( 1.1 ) the treatment of agitation associated with dementia due to Alzheimer’s disease ( 1.2 ) Limitations of Use: AUVELITY is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease (1.2). 1.1 Major Depressive Disorder AUVELITY is indicated for the treatment of major depressive disorder (MDD) in adults. 1.2 Agitation Associated with Dementia Due to Alzheimer’s Disea…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 81968-045

What is NDC 81968-045?: 81968-045 is the product NDC for Auvelity, Dextromethorphan hydrobromide 45 mg/1; Bupropion hydrochloride 105 mg/1 tablet, multilayer, extended release, listed with the FDA by Axsome Therapeutics, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Auvelity (Dextromethorphan hydrobromide, bupropion hydrochloride).
What is the active ingredient?: Dextromethorphan hydrobromide, Bupropion hydrochloride.
Who is the labeler?: Axsome Therapeutics, Inc., NDC labeler code 81968. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Auvelity?: 3 other product NDCs are listed under this name. See all Auvelity 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 Auvelity NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Auvelitydextromethorphan hydrobromide, bupropion hydrochloride	—	Kit	Axsome Therapeutics, Inc.	81968-453	81968-0453-01
Auvelitydextromethorphan hydrobromide, bupropion hydrochloride	—	Kit	Axsome Therapeutics, Inc.	81968-345	81968-0345-0181968-0345-03
Auvelitydextromethorphan hydrobromide, bupropion hydrochloride	Dextromethorphan hydrobromide 30 mg/1; Bupropion hydrochloride 105 mg/1	Tablet, Multilayer, Extended releaseOral	Axsome Therapeutics, Inc.	81968-030	81968-0030-22

Other NDCs under NDA 215430

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

FDA NDC Directory listings under NDA 215430
Product	Strength	Form · route	Labeler	Product NDC
Auvelitydextromethorphan hydrobromide, bupropion hydrochloride	Dextromethorphan hydrobromide 30 mg/1; Bupropion hydrochloride 105 mg/1	Tablet, Multilayer, Extended releaseOral	Axsome Therapeutics, Inc.	81968-030
Auvelitydextromethorphan hydrobromide, bupropion hydrochloride	—	Kit	Axsome Therapeutics, Inc.	81968-345
Auvelitydextromethorphan hydrobromide, bupropion hydrochloride	—	Kit	Axsome Therapeutics, Inc.	81968-453