Prescription drug · ANDA
Estazolam NDC 75907-029
Estazolam 2 mg/1 · Tablet · Oral · Dr. Reddy's Labratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75907-029-01 | 75907002901 | 100 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
N475907002901followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Estazolam products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | Novitium Pharma LLC | 70954-481 | 70954-0481-10 |
| Estazolam | Estazolam 1 mg/1 | TabletOral | Novitium Pharma LLC | 70954-480 | 70954-0480-10 |
| 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 074921
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Estazolam | Estazolam 1 mg/1 | TabletOral | Dr. Reddy's Labratories Inc. | 75907-028 |