NDC codes

FDA NDC Directory
Product NDC (as listed)75907-029Labeler and product segments. Claims need a package NDC.
Product NDC at billing width75907-0029Add 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
75907-029-0175907002901100 TABLET in 1 BOTTLE, PLASTIC (75907-029-01)Marketed from Feb 15, 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)
Estazolam
Generic name (nonproprietary)
estazolam
Active ingredients
Estazolam — 2 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Dr. Reddy's Labratories Inc.NDC labeler code 75907
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074921
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Benzodiazepines (Chemical structure)
Identifiers
Product ID 75907-029_72da6d6d-2d81-d7a4-6454-2b8967981feaSPL ID 72da6d6d-2d81-d7a4-6454-2b8967981feaSPL set ID 2f349a44-6d04-01d1-c8b7-12254aead77dRxCUI 197653, 197654UNII 36S3EQV54C
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

N475907002901 followed by a unit qualifier and the quantity

Package 75907-0029-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND 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 b…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 75907-029

What is NDC 75907-029?
75907-029 is the product NDC for Estazolam, Estazolam 2 mg/1 tablet, listed with the FDA by Dr. Reddy's Labratories 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?
Dr. Reddy's Labratories Inc., NDC labeler code 75907. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
EstazolamEstazolam 1 mg/1TabletOralDr. Reddy's Labratories Inc.75907-02875907-0028-01
EstazolamEstazolam 2 mg/1TabletOralNovitium Pharma LLC70954-48170954-0481-10
EstazolamEstazolam 1 mg/1TabletOralNovitium Pharma LLC70954-48070954-0480-10
EstazolamEstazolam 1 mg/1TabletOralActavis Pharma, Inc.0591-074400591-0744-01
EstazolamEstazolam 2 mg/1TabletOralActavis Pharma, Inc.0591-074500591-0745-01

Other NDCs under ANDA 074921

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

FDA NDC Directory listings under ANDA 074921
ProductStrengthForm · routeLabelerProduct NDC
EstazolamEstazolam 1 mg/1TabletOralDr. Reddy's Labratories Inc.75907-028

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