What is NDC 76420-653?

76420-653 is the product NDC for Alprazolam, Alprazolam 2 mg/1 tablet, extended release, listed with the FDA by Asclemed USA, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Alprazolam?

114 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Alprazolam NDC 76420-653 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-653Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0653Add 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
76420-653-30	76420065330	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-653-30)Marketed from Jan 5, 2024
76420-653-60	76420065360	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-653-60)Marketed from Jan 5, 2024
76420-653-90	76420065390	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-653-90)Marketed from Jan 5, 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): Alprazolam
Generic name (nonproprietary): alprazolam
Active ingredients: Alprazolam — 2 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090871
Marketing start: Jun 7, 2011
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 76420-653_0e42e402-85e4-30a1-e063-6394a90a142cSPL ID 0e42e402-85e4-30a1-e063-6394a90a142cSPL set ID 5d839a8b-0f45-42bf-acc1-2bd28f948e53RxCUI 433798, 433799, 433800, 433801UNII 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

N476420065330 followed by a unit qualifier and the quantity

Package 76420-0653-30. 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 Jan 6, 2024. 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)

About NDC 76420-653

What is NDC 76420-653?: 76420-653 is the product NDC for Alprazolam, Alprazolam 2 mg/1 tablet, extended release, listed with the FDA by Asclemed USA, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Alprazolam.
What is the active ingredient?: Alprazolam.
Who is the labeler?: Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Alprazolam?: 114 other product NDCs are listed under this name. See all Alprazolam 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 Alprazolam NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Alprazolam	Alprazolam 1 mg/1	TabletOral	Coupler LLC	67046-0007	67046-0007-03
Alprazolam	Alprazolam .5 mg/1	TabletOral	Coupler LLC	67046-0154	67046-0154-03
Alprazolam	Alprazolam .25 mg/1	TabletOral	AvPAK	50268-033	50268-0033-15
Alprazolam	Alprazolam .5 mg/1	TabletOral	AvPAK	50268-034	50268-0034-15
Alprazolam	Alprazolam 1 mg/1	TabletOral	AvPAK	50268-035	50268-0035-15
Alprazolam	Alprazolam 1 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0444	80425-0444-0180425-0444-02
Alprazolam	Alprazolam .25 mg/1	TabletOral	Northwind Health Company, LLC	82868-061	82868-0061-30
Alprazolam	Alprazolam 1 mg/1	TabletOral	REMEDYREPACK INC.	70518-4137	70518-4137-00
Alprazolam	Alprazolam .5 mg/1	TabletOral	American Health Packaging	60687-388	60687-0388-01
Alprazolam	Alprazolam .25 mg/1	TabletOral	American Health Packaging	60687-377	60687-0377-01

All 115 Alprazolam NDCs

Other NDCs under ANDA 090871

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

FDA NDC Directory listings under ANDA 090871
Product	Strength	Form · route	Labeler	Product NDC
Alprazolam	Alprazolam 1 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	63187-445
Alprazolam	Alprazolam .5 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	63187-518
Alprazolam	Alprazolam 1 mg/1	Tablet, Extended releaseOral	Aurobindo Pharma Limited	65862-455
Alprazolam	Alprazolam .5 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-1669
Alprazolam	Alprazolam 1 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-1839
Alprazolam	Alprazolam 1 mg/1	Tablet, Extended releaseOral	Asclemed USA, Inc.	76420-651
Alprazolam	Alprazolam .5 mg/1	Tablet, Extended releaseOral	Asclemed USA, Inc.	76420-652
Alprazolam	Alprazolam 3 mg/1	Tablet, Extended releaseOral	Asclemed USA, Inc.	76420-654