Home NDC 44567-402 Meropenem
Product NDC 44567-402
11-digit product format 445670402
Labeler code 44567
Product ID 44567-402_cfbea700-158d-497c-9810-f85b5ccf3023
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meropenem
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler WG Critical Care, LLC
Application NDA215212
Marketing category NDA
Marketing start 2023-09-08
Substance MEROPENEM
Active strength 2 g/1
Pharmacologic classes Carbapenems [CS], Penem Antibacterial [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215212-001 MEROPENEM MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS AP RLD, RS 2023-07-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N215212-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS AP RLD, RS 2023-07-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS AP RLD, RS 2023-07-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS AP RLD, RS 2023-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS AP RLD, RS 2023-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS AP RLD, RS 2023-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2023-07-26 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215212-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS AP RLD, RS 2023-07-26 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Meropenem
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEROPENEM 2 g/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44567-402-01 Meropenem 1 in 1 VIAL INJECTION, POWDER, FOR SOLUTION 1 4 44567-402-06 Meropenem 6 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 6 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44567-402 MEROPENEM INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC] 3 Current NDC, 2 package rows 20231103_240325ba-47a8-4ad1-bcab-6772069ee790.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 44567-402-01 44567040201 1 in 1 VIAL Historical 44567-402-06 44567040206 6 VIAL in 1 CARTON (44567-402-06) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (44567-402-01) 6 vial 2023-09-08 No No Current