NDC 0069-0313

MERREM IV

Meropenem

MERREM IV is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Meropenem.

• Product ID: 0069-0313_1f2b69a8-38b6-48ea-b502-a6e8a7d7602e
• NDC: 0069-0313
• Product Type: Human Prescription Drug
• Proprietary Name: MERREM IV
• Generic Name: Meropenem
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-07-16
• Marketing Category: NDA / NDA
• Application Number: NDA050706
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: MEROPENEM
• Active Ingredient Strength: 500 mg/20mL
• Pharm Classes: Carbapenems [CS],Penem Antibacterial [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0069-0313-10

10 VIAL in 1 CARTON (0069-0313-10) > 20 mL in 1 VIAL (0069-0313-01)

• Marketing Start Date: 2018-07-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-0313-01 [00069031301]

MERREM IV INJECTION

• Marketing Category: NDA
• Application Number: NDA050706
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-16

NDC 0069-0313-10 [00069031310]

MERREM IV INJECTION

• Marketing Category: NDA
• Application Number: NDA050706
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-16

Drug Details

Active Ingredients

Ingredient	Strength
MEROPENEM	500 mg/20mL

OpenFDA Data

• SPL SET ID: 8f0c2a90-956a-4430-b26d-00d48169a9b0
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • FV9J3JU8B1
• RxNorm Concept Unique ID - RxCUI:
  • 1722937
  • 1722934
  • 1722941
  • 1722939

Pharmacological Class

• Carbapenems [CS]
• Penem Antibacterial [EPC]

NDC Crossover Matching brand name "MERREM IV" or generic name "Meropenem"

NDC	Brand Name	Generic Name
0409-0222	Meropenem	Meropenem
0409-1390	Meropenem	Meropenem
0409-1391	Meropenem	Meropenem
0409-3412	Meropenem	Meropenem
0409-3505	Meropenem	MEROPENEM
0409-3506	Meropenem	MEROPENEM
0781-3000	MEROPENEM	MEROPENEM
0781-3098	MEROPENEM	MEROPENEM
0781-3265	Meropenem	Meropenem
0781-3267	Meropenem	Meropenem
25021-155	Meropenem	meropenem
25021-156	Meropenem	meropenem
44567-145	Meropenem	Meropenem
0069-0313	MERREM	Meropenem
0069-0314	MERREM	Meropenem
0310-0321	MERREM	Meropenem
0310-0325	MERREM	Meropenem