NDC 0781-3000

MEROPENEM

Meropenem

MEROPENEM is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Meropenem.

• Product ID: 0781-3000_313c6444-c110-400c-9532-bd5a02555ebd
• NDC: 0781-3000
• Product Type: Human Prescription Drug
• Proprietary Name: MEROPENEM
• Generic Name: Meropenem
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-08-29
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206086
• Labeler Name: Sandoz Inc
• Substance Name: MEROPENEM
• Active Ingredient Strength: 500 mg/20mL
• Pharm Classes: Carbapenems [CS],Penem Antibacterial [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0781-3000-95

10 VIAL in 1 CARTON (0781-3000-95) > 20 mL in 1 VIAL (0781-3000-94)

• Marketing Start Date: 2016-08-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0781-3000-96 [00781300096]

MEROPENEM INJECTION

• Marketing Category: ANDA
• Application Number: ANDA206086
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-08-29

NDC 0781-3000-95 [00781300095]

MEROPENEM INJECTION

• Marketing Category: ANDA
• Application Number: ANDA206086
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-08-29

NDC 0781-3000-94 [00781300094]

MEROPENEM INJECTION

• Marketing Category: ANDA
• Application Number: ANDA206086
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-08-29

Drug Details

Active Ingredients

Ingredient	Strength
MEROPENEM	500 mg/20mL

OpenFDA Data

• SPL SET ID: 0d37e43b-ff8d-495d-b9af-4fd5fce53d56
• Manufacturer:
  • Sandoz Inc
• UNII:
  • FV9J3JU8B1
• RxNorm Concept Unique ID - RxCUI:
  • 1722934
  • 1722939

Pharmacological Class

• Carbapenems [CS]
• Penem Antibacterial [EPC]

NDC Crossover Matching brand name "MEROPENEM" 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
68001-324	Meropenem	Meropenem
68001-323	Meropenem	Meropenem
68083-147	Meropenem	Meropenem
68083-146	Meropenem	Meropenem
70278-103	Meropenem	Meropenem
70121-1453	Meropenem	Meropenem
70121-1454	Meropenem	Meropenem
70278-104	Meropenem	Meropenem
44647-032	MEROPENEM	MEROPENEM
44647-033	MEROPENEM	MEROPENEM
55150-208	Meropenem	Meropenem
55150-207	Meropenem	Meropenem
63323-508	Meropenem	Meropenem
63323-507	Meropenem	Meropenem
0069-0313	MERREM	Meropenem
0069-0314	MERREM	Meropenem
0310-0321	MERREM	Meropenem
0310-0325	MERREM	Meropenem