NDC 71288-015

Meropenem

Meropenem

Meropenem is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Meitheal Pharmaceuticals Inc.. The primary component is Meropenem.

Product ID71288-015_4e6b647a-85da-4d45-82f9-8441f1b22826
NDC71288-015
Product TypeHuman Prescription Drug
Proprietary NameMeropenem
Generic NameMeropenem
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-11-04
Marketing CategoryANDA / ANDA
Application NumberANDA204858
Labeler NameMeitheal Pharmaceuticals Inc.
Substance NameMEROPENEM
Active Ingredient Strength1 g/1
Pharm ClassesCarbapenems [CS],Penem Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71288-015-31

10 VIAL, SINGLE-DOSE in 1 CARTON (71288-015-31) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-015-30)
Marketing Start Date2019-11-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71288-015-30 [71288001530]

Meropenem INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204858
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-04

NDC 71288-015-31 [71288001531]

Meropenem INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204858
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-04

Drug Details

Active Ingredients

IngredientStrength
MEROPENEM1 g/1

Pharmacological Class

  • Carbapenems [CS]
  • Penem Antibacterial [EPC]
  • Carbapenems [CS]
  • Penem Antibacterial [EPC]

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

NDCBrand NameGeneric Name
0409-0222MeropenemMeropenem
0409-1390MeropenemMeropenem
0409-1391MeropenemMeropenem
0409-3412MeropenemMeropenem
0409-3505MeropenemMEROPENEM
0409-3506MeropenemMEROPENEM
0781-3000MEROPENEMMEROPENEM
0781-3098MEROPENEMMEROPENEM
0781-3265MeropenemMeropenem
0781-3267MeropenemMeropenem
25021-155Meropenemmeropenem
25021-156Meropenemmeropenem
44567-145MeropenemMeropenem
68001-324MeropenemMeropenem
68001-323MeropenemMeropenem
68083-147MeropenemMeropenem
68083-146MeropenemMeropenem
70278-103MeropenemMeropenem
70121-1453MeropenemMeropenem
70121-1454MeropenemMeropenem
70278-104MeropenemMeropenem
44647-032MEROPENEMMEROPENEM
44647-033MEROPENEMMEROPENEM
55150-208MeropenemMeropenem
55150-207MeropenemMeropenem
63323-508MeropenemMeropenem
63323-507MeropenemMeropenem
0069-0313MERREMMeropenem
0069-0314MERREMMeropenem
0310-0321MERREMMeropenem
0310-0325MERREMMeropenem
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.