What is NDC 70954-480?

70954-480 is the product NDC for Estazolam, Estazolam 1 mg/1 tablet, listed with the FDA by Novitium Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Novitium Pharma LLC, NDC labeler code 70954. 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 70954-480 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70954-480Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70954-0480Add 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
70954-480-10	70954048010	100 TABLET in 1 BOTTLE (70954-480-10)Marketed from Apr 8, 2021

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): Estazolam
Generic name (nonproprietary): estazolam
Active ingredients: Estazolam — 1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Novitium Pharma LLCNDC labeler code 70954
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074826
Marketing start: Apr 8, 2021
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 70954-480_2a612458-8b9a-4125-a783-44327a8166d9SPL ID 2a612458-8b9a-4125-a783-44327a8166d9SPL set ID e1c77eb1-9cba-4e89-a03f-9fb797add4f0RxCUI 197653, 197654UNII 36S3EQV54CUPC 0370954480105, 0370954481102
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

N470954048010 followed by a unit qualifier and the quantity

Package 70954-0480-10. 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 Nov 11, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & USAGE Estazolam is 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 treatment should be …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70954-480

What is NDC 70954-480?: 70954-480 is the product NDC for Estazolam, Estazolam 1 mg/1 tablet, listed with the FDA by Novitium Pharma LLC. 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?: Novitium Pharma LLC, NDC labeler code 70954. 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 2 mg/1	TabletOral	Novitium Pharma LLC	70954-481	70954-0481-10
Estazolam	Estazolam 1 mg/1	TabletOral	Actavis Pharma, Inc.	0591-0744	00591-0744-01
Estazolam	Estazolam 2 mg/1	TabletOral	Actavis Pharma, Inc.	0591-0745	00591-0745-01

Other NDCs under ANDA 074826

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

FDA NDC Directory listings under ANDA 074826
Product	Strength	Form · route	Labeler	Product NDC
Estazolam	Estazolam 2 mg/1	TabletOral	Novitium Pharma LLC	70954-481