Meropenem

Product NDC
70278-104
11-digit product format
702780104
Labeler code
70278
Product ID
70278-104_eed23a09-bc93-c40b-e053-2a95a90a4a1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meropenem
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Daewoong America Inc.
Application
ANDA204854
Marketing category
ANDA
Marketing start
2016-10-08
Marketing end
0000-00-00
Substance
MEROPENEM
Active strength
1 g/30mL
Pharmacologic classes
Carbapenems [CS], Penem Antibacterial [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70278-104-022024-06-12C16284748780-11030e364-fc27-111a-e063-dadaa90a10e2ee58bb66-26b8-4dc5-a029-d6df324495cd
70278-104-022024-01-30C16284748780-11030e364-fc27-111a-e063-dadaa90a10e2ee58bb66-26b8-4dc5-a029-d6df324495cd

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70278-104-027027801040210 VIAL in 1 CARTON (70278-104-02) > 30 mL in 1 VIAL (70278-104-01) 10 vial2016-10-080000-00-00NoNoCurrent