NDC codes

FDA NDC Directory
Product NDC (as listed)65162-809Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65162-0809Add 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
65162-809-036516208090330 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-809-03)Marketed from Dec 3, 2009
65162-809-066516208090660 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-809-06)Marketed from Dec 3, 2009
65162-809-5065162080950500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-809-50)Marketed from Dec 3, 2009

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)
Alprazolam
Generic name (nonproprietary)
alprazolam
Active ingredients
Alprazolam — .5 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078387
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Benzodiazepines (Chemical structure)
Identifiers
Product ID 65162-809_4b2e21bc-ca1c-4ff5-a996-32f1e94d2a91SPL ID 4b2e21bc-ca1c-4ff5-a996-32f1e94d2a91SPL set ID 259387c1-e374-4bc2-9510-5f7f2c60d1a5RxCUI 433798, 433799, 433800, 433801UNII YU55MQ3IZYUPC 0365162809503, 0365162810509, 0365162813500, 0365162809039, 0365162810035, 0365162813036, 0365162812039, 0365162812503
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

N465162080903 followed by a unit qualifier and the quantity

Package 65162-0809-03. 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)

Alprazolam extended-release tablets are indicated for the treatment of panic disorder with or without agoraphobia, in adults. Alprazolam extended-release tablets are a benzodiazepine indicated for the treatment of panic disorder with or without agoraphobia, in adults. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078387

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

FDA NDC Directory listings under ANDA 078387
ProductStrengthForm · routeLabelerProduct NDC
AlprazolamAlprazolam 3 mg/1Tablet, Extended releaseOralAmneal Pharmaceuticals LLC65162-813
AlprazolamAlprazolam 1 mg/1Tablet, Extended releaseOralAmneal Pharmaceuticals LLC65162-810
AlprazolamAlprazolam 2 mg/1Tablet, Extended releaseOralAmneal Pharmaceuticals LLC65162-812

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