NDC 43598-548

Propofol Injectable Emulsion

Propofol Injectable Emulsion

Propofol Injectable Emulsion is a Intravenous Injection, Emulsion in the Human Prescription Drug category. It is labeled and distributed by Dr. Reddy's Laboratories, Inc.. The primary component is Propofol.

• Product ID: 43598-548_31eb20bd-1546-77d7-327b-8fbb905f69b6
• NDC: 43598-548
• Product Type: Human Prescription Drug
• Proprietary Name: Propofol Injectable Emulsion
• Generic Name: Propofol Injectable Emulsion
• Dosage Form: Injection, Emulsion
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-11-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205067
• Labeler Name: Dr. Reddy's Laboratories, Inc.
• Substance Name: PROPOFOL
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: General Anesthesia [PE],General Anesthetic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 43598-548-21

20 VIAL in 1 CARTON (43598-548-21) > 50 mL in 1 VIAL (43598-548-50)

• Marketing Start Date: 2018-11-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43598-548-50 [43598054850]

Propofol Injectable Emulsion INJECTION, EMULSION

• Marketing Category: ANDA
• Application Number: ANDA205067
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-11-15

NDC 43598-548-21 [43598054821]

Propofol Injectable Emulsion INJECTION, EMULSION

• Marketing Category: ANDA
• Application Number: ANDA205067
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-11-15

Drug Details

Active Ingredients

Ingredient	Strength
PROPOFOL	10 mg/mL

OpenFDA Data

• SPL SET ID: 800646b8-83a8-01d9-3dc8-bb2ddcb8570c
• Manufacturer:
  • Dr. Reddy's Laboratories, Inc.
• UNII:
  • YI7VU623SF
• RxNorm Concept Unique ID - RxCUI:
  • 1808217
  • 1808224
  • 1808222

Pharmacological Class

• General Anesthesia [PE]
• General Anesthetic [EPC]
• General Anesthesia [PE]
• General Anesthetic [EPC]

NDC Crossover Matching brand name "Propofol Injectable Emulsion" or generic name "Propofol Injectable Emulsion"

NDC	Brand Name	Generic Name
43598-265	Propofol Injectable Emulsion	Propofol Injectable Emulsion
43598-548	Propofol Injectable Emulsion	Propofol Injectable Emulsion
43598-549	Propofol Injectable Emulsion	Propofol Injectable Emulsion