What is NDC 0591-0744?

0591-0744 is the product NDC for Estazolam, Estazolam 1 mg/1 tablet, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Actavis Pharma, Inc., NDC labeler code 0591. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Estazolam?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Estazolam NDC 0591-0744 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-0744Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-0744Add 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
0591-0744-01	0059107440100591074401	100 TABLET in 1 BOTTLE, PLASTIC (0591-0744-01)Marketed from Oct 1, 1997

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): Estazolam
Generic name (nonproprietary): estazolam
Active ingredients: Estazolam — 1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Actavis Pharma, Inc.NDC labeler code 0591
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074818
Marketing start: Oct 1, 1997
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 0591-0744_5189e5a6-f58a-4eab-ac95-9d8011d6f3dbSPL ID 5189e5a6-f58a-4eab-ac95-9d8011d6f3dbSPL set ID a1e3b4bf-22e9-430a-a768-4d86ae886c9eRxCUI 197653, 197654UNII 36S3EQV54CUPC 0305910745011, 0305910744014
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

N400591074401 followed by a unit qualifier and the quantity

Package 00591-0744-01. 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 Jun 30, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Estazolam tablets, USP are indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. Both outpatient studies and a sleep laboratory study have shown that estazolam administered at bedtime improved sleep induction and sleep maintenance (see CLINICAL PHARMACOLOGY ). Because insomnia is often transient and intermittent, the prolonged administration of estazolam is generally neither necessary nor recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific trea…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0591-0744

What is NDC 0591-0744?: 0591-0744 is the product NDC for Estazolam, Estazolam 1 mg/1 tablet, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Estazolam.
What is the active ingredient?: Estazolam.
Who is the labeler?: Actavis Pharma, Inc., NDC labeler code 0591. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Estazolam?: 5 other product NDCs are listed under this name. See all Estazolam 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 Estazolam NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Estazolam	Estazolam 1 mg/1	TabletOral	Dr. Reddy's Labratories Inc.	75907-028	75907-0028-01
Estazolam	Estazolam 2 mg/1	TabletOral	Dr. Reddy's Labratories Inc.	75907-029	75907-0029-01
Estazolam	Estazolam 1 mg/1	TabletOral	Novitium Pharma LLC	70954-480	70954-0480-10
Estazolam	Estazolam 2 mg/1	TabletOral	Novitium Pharma LLC	70954-481	70954-0481-10
Estazolam	Estazolam 2 mg/1	TabletOral	Actavis Pharma, Inc.	0591-0745	00591-0745-01