Prescription drug · ANDA

Zolpidem Tartrate NDC 16714-621

Zolpidem tartrate 5 mg/1 · Tablet, Film coated · Oral · NorthStar Rx LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)16714-621Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0621Add 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
16714-621-0116714062101100 TABLET, FILM COATED in 1 BOTTLE (16714-621-01)Marketed from May 4, 2007
16714-621-0216714062102500 TABLET, FILM COATED in 1 BOTTLE (16714-621-02)Marketed from May 4, 2007
16714-621-111671406211110 BLISTER PACK in 1 CARTON (16714-621-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (16714-621-10)Marketed from May 4, 2007

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)
Zolpidem Tartrate
Generic name (nonproprietary)
zolpidem tartrate
Active ingredients
Zolpidem tartrate — 5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078413
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Central Nervous System Depression (Physiologic effect)GABA A Agonists (Mechanism)Pyridines (Chemical structure)
Identifiers
Product ID 16714-621_8d310ac3-c04b-4a08-babe-406d574c5ce3SPL ID 8d310ac3-c04b-4a08-babe-406d574c5ce3SPL set ID 51c9a29c-a285-40d0-bf3a-7e8c944ee39cRxCUI 854873, 854876UNII WY6W63843KUPC 0316714621012, 0316714622019
Pharmacologic class
gamma-Aminobutyric Acid-ergic Agonist

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

N416714062101 followed by a unit qualifier and the quantity

Package 16714-0621-01. 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)

Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14) ] . The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem tartrate tablets, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078413

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

FDA NDC Directory listings under ANDA 078413
ProductStrengthForm · routeLabelerProduct NDC
Zolpidem TartrateZolpidem tartrate 5 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-159
Zolpidem TartrateZolpidem tartrate 10 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-160
Zolpidem TartrateZolpidem tartrate 10 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0153
Zolpidem TartrateZolpidem tartrate 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2649
Zolpidem TartrateZolpidem tartrate 10 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-622
Zolpidem TartrateZolpidem tartrate 5 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-838
Zolpidem TartrateZolpidem tartrate 10 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-323
Zolpidem TartrateZolpidem tartrate 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7434
Zolpidem TartrateZolpidem tartrate 10 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-152
Zolpidem TartrateZolpidem tartrate 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6070
Zolpidem TartrateZolpidem tartrate 5 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-151
Zolpidem TartrateZolpidem tartrate 5 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-156
Zolpidem TartrateZolpidem tartrate 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3943
Zolpidem TartrateZolpidem tartrate 5 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-416
Zolpidem TartrateZolpidem tartrate 10 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-417
Zolpidem TartrateZolpidem tartrate 10 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0061
Zolpidem TartrateZolpidem tartrate 10 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-192
Zolpidem TartrateZolpidem tartrate 5 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-390
Zolpidem TartrateZolpidem tartrate 5 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0087
Zolpidem TartrateZolpidem tartrate 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3879

Showing 20 of 23.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in
Zolpidem Tartrate NDC 16714-621 | Med-Code