NDC 69543-412

Levorphanol Tartrate

Levorphanol Tartrate

Levorphanol Tartrate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Virtus Pharmaceuticals, Llc. The primary component is Levorphanol Tartrate.

• Product ID: 69543-412_28501185-fe1f-47e5-ace9-b1dca5b2eca0
• NDC: 69543-412
• Product Type: Human Prescription Drug
• Proprietary Name: Levorphanol Tartrate
• Generic Name: Levorphanol Tartrate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-12-13
• Marketing Category: ANDA / ANDA
• Application Number: ANDA211484
• Labeler Name: Virtus Pharmaceuticals, LLC
• Substance Name: LEVORPHANOL TARTRATE
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69543-412-10

100 TABLET in 1 BOTTLE (69543-412-10)

• Marketing Start Date: 2018-12-13
• Marketing End Date: 2024-02-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69543-412-10 [69543041210]

Levorphanol Tartrate TABLET

• Marketing Category: ANDA
• Application Number: ANDA211484
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-12-13

Drug Details

Active Ingredients

Ingredient	Strength
LEVORPHANOL TARTRATE	2 mg/1

OpenFDA Data

• SPL SET ID: 85b9fc9e-e09f-4297-af8f-c9b338f78503
• Manufacturer:
  • Virtus Pharmaceuticals, LLC
• UNII:
  • 04WQU6T9QI
• RxNorm Concept Unique ID - RxCUI:
  • 197873
• UPC Code:
  • 0369543412108

Pharmacological Class

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]

NDC Crossover Matching brand name "Levorphanol Tartrate" or generic name "Levorphanol Tartrate"

NDC	Brand Name	Generic Name
0406-2224	Levorphanol Tartrate	Levorphanol Tartrate
0527-3236	Levorphanol Tartrate	Levorphanol Tartrate
0527-3237	Levorphanol Tartrate	Levorphanol Tartrate
42358-101	Levorphanol Tartrate	Levorphanol Tartrate
42358-102	Levorphanol Tartrate	Levorphanol Tartrate
42358-103	Levorphanol Tartrate	Levorphanol Tartrate
57664-762	Levorphanol Tartrate	Levorphanol Tartrate
63629-2093	Levorphanol Tartrate	Levorphanol Tartrate
69543-412	Levorphanol Tartrate	Levorphanol Tartrate
69543-417	Levorphanol Tartrate	Levorphanol Tartrate
70954-236	Levorphanol Tartrate	Levorphanol Tartrate