Home NDC 44567-402 Meropenem
Product NDC 44567-402
11-digit product format 445670402
Labeler code 44567
Product ID 44567-402_65ec9fc3-b50a-481f-8fe4-011b0c848503
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 1 .
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 2026-02-19 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# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 N215212-001 AP 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215212-001 AP 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215212-001 AP 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215212-001 AP 1 a50c72e98297…
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
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FV9J3JU8B1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2664894 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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