Estazolam NDC 0591-0744

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	00591074401	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.
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)

Other NDCs under ANDA 074818

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

FDA NDC Directory listings under ANDA 074818
Product	Strength	Form · route	Labeler	Product NDC
Estazolam	Estazolam 2 mg/1	TabletOral	Actavis Pharma, Inc.	0591-0745