Alprazolam NDC 0228-4022

NDC codes

FDA NDC Directory

Product NDC (as listed)0228-4022Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00228-4022Add 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
0228-4022-11	00228402211	100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0228-4022-11)Marketed from Mar 17, 2010

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Alprazolam
Generic name (nonproprietary): alprazolam
Active ingredients: Alprazolam — .5 mg/1
Dosage form: Tablet, Orally disintegrating
Route: Oral
Labeler: Actavis Pharma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078561
Marketing start: Mar 17, 2010
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 0228-4022_38c5b407-25a1-48f5-960e-87ef637b644cSPL ID 38c5b407-25a1-48f5-960e-87ef637b644cSPL set ID 5ceed721-2e65-4c81-bd84-f110b1ac9d2eRxCUI 485413, 485414, 485415, 485416UNII YU55MQ3IZY
Pharmacologic class: Benzodiazepine

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

N400228402211 followed by a unit qualifier and the quantity

Package 00228-4022-11. 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 1, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

Alprazolam orally disintegrating tablets are a benzodiazepine indicated for: The treatment of generalized anxiety disorder ( 1.1 ). The efficacy of alprazolam was demonstrated in 5 short-term, placebo-controlled trials. ( 14 ). The treatment of panic disorder, with or without agoraphobia ( 1.2 ). The efficacy of alprazolam in the treatment of panic disorder was established in 2 short-term, placebo-controlled trials ( 14 ). 1.1 Generalized Anxiety Disorder Alprazolam orally disintegrating tablets, USP are indicated for the treatment of generalized anxiety disorder. The efficacy of alprazolam in the treatment of generalized anxiety disorder was demonstrated in 5 short-term, placebo-controlled …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078561

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

FDA NDC Directory listings under ANDA 078561
Product	Strength	Form · route	Labeler	Product NDC
Alprazolam	Alprazolam .25 mg/1	Tablet, Orally disintegratingOral	Actavis Pharma, Inc.	0228-4019
Alprazolam	Alprazolam 1 mg/1	Tablet, Orally disintegratingOral	Actavis Pharma, Inc.	0228-4024
Alprazolam	Alprazolam 2 mg/1	Tablet, Orally disintegratingOral	Actavis Pharma, Inc.	0228-4025