Edluar (zolpidem tartrate) NDC 0037-6050

NDC codes

FDA NDC Directory

Product NDC (as listed)0037-6050Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00037-6050Add 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
0037-6050-93	00037605093	5 BLISTER PACK in 1 CARTON (0037-6050-93) / 6 TABLET in 1 BLISTER PACK (0037-6050-35)Marketed from Feb 16, 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 — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Viatris Specialty LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021997
Marketing start: Jul 24, 2009
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Central Nervous System Depression (Physiologic effect)GABA A Receptor Positive Modulators (Mechanism)
Identifiers: Product ID 0037-6050_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

N400037605093 followed by a unit qualifier and the quantity

Package 00037-6050-93. 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 Aug 15, 2022. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021997

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

FDA NDC Directory listings under NDA 021997
Product	Strength	Form · route	Labeler	Product NDC
Edluarzolpidem tartrate	Zolpidem tartrate 10 mg/1	TabletOral	Viatris Specialty LLC	0037-6010