Prescription drug · NDA
Edluar (Zolpidem tartrate) NDC 0037-6010
Zolpidem tartrate 10 mg/1 · Tablet · Oral · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0037-6010-93 | 0003760109300037601093 | 5 BLISTER PACK in 1 CARTON (0037-6010-93) / 6 TABLET in 1 BLISTER PACK (0037-6010-35)Marketed from Jul 20, 2022 |
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)
- Edluar
- Generic name (nonproprietary)
- zolpidem tartrate
- Active ingredients
- Zolpidem tartrate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Viatris Specialty LLCNDC labeler code 0037
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021997
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Central Nervous System Depression (Physiologic effect)GABA A Receptor Positive Modulators (Mechanism)
- Identifiers
- Product ID 0037-6010_f9d32621-9e2f-4dbf-8189-c5ab3168b5d2SPL ID f9d32621-9e2f-4dbf-8189-c5ab3168b5d2SPL set ID a32884d0-85b5-11de-8a39-0800200c9a66RxCUI 836641, 836645, 836647, 836649UNII WY6W63843K
- Pharmacologic class
- gamma-Aminobutyric Acid A Receptor Positive Modulator
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
N400037601093followed by a unit qualifier and the quantityPackage 00037-6010-93. 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)
Edluar (zolpidem tartrate) sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation [see Clinical Studies (14) ] . The clinical trials performed with zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Edluar, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0037-6010
- What is NDC 0037-6010?
- 0037-6010 is the product NDC for Edluar (zolpidem tartrate), Zolpidem tartrate 10 mg/1 tablet, listed with the FDA by Viatris Specialty LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Edluar (Zolpidem Tartrate).
- What is the active ingredient?
- Zolpidem tartrate.
- Who is the labeler?
- Viatris Specialty LLC, NDC labeler code 0037. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Edluar?
- 1 other product NDC are listed under this name. See all Edluar NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Edluar products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Edluarzolpidem tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Viatris Specialty LLC | 0037-6050 | 00037-6050-93 |
Other NDCs under NDA 021997
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 |
|---|---|---|---|---|
| Edluarzolpidem tartrate | Zolpidem tartrate 5 mg/1 | TabletOral | Viatris Specialty LLC | 0037-6050 |