NDC 49884-899

Zolpidem tartrate sublingual

Zolpidem Tartrate Sublingual

Zolpidem tartrate sublingual is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Zolpidem Tartrate.

• Product ID: 49884-899_5f90507a-be73-426f-858c-289367d24ac1
• NDC: 49884-899
• Product Type: Human Prescription Drug
• Proprietary Name: Zolpidem tartrate sublingual
• Generic Name: Zolpidem Tartrate Sublingual
• Dosage Form: Tablet
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2017-09-11
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204229
• Labeler Name: Par Pharmaceutical, Inc.
• Substance Name: ZOLPIDEM TARTRATE
• Active Ingredient Strength: 4 mg/1
• Pharm Classes: gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
• DEA Schedule: CIV
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 49884-899-11

30 POUCH in 1 CARTON (49884-899-11) > 1 TABLET in 1 POUCH (49884-899-52)

• Marketing Start Date: 2017-09-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49884-899-52 [49884089952]

Zolpidem tartrate sublingual TABLET

• Marketing Category: ANDA
• Application Number: ANDA204229
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-09-11

NDC 49884-899-11 [49884089911]

Zolpidem tartrate sublingual TABLET

• Marketing Category: ANDA
• Application Number: ANDA204229
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-09-11

Drug Details

Active Ingredients

Ingredient	Strength
ZOLPIDEM TARTRATE	3.5 mg/1

OpenFDA Data

• SPL SET ID: 44b34e58-114b-4774-9fab-4b188dfe0228
• Manufacturer:
  • Par Pharmaceutical, Inc.
• UNII:
  • WY6W63843K
• RxNorm Concept Unique ID - RxCUI:
  • 1232202
  • 1232194
• UPC Code:
  • 0349884899523
  • 0349884898526

Pharmacological Class

• gamma-Aminobutyric Acid-ergic Agonist [EPC]
• GABA A Agonists [MoA]
• Pyridines [CS]
• Central Nervous System Depression [PE]

NDC Crossover Matching brand name "Zolpidem tartrate sublingual" or generic name "Zolpidem Tartrate Sublingual"

NDC	Brand Name	Generic Name
49884-898	Zolpidem tartrate sublingual	Zolpidem tartrate sublingual
49884-899	Zolpidem tartrate sublingual	Zolpidem tartrate sublingual