Home NDC 81962-002 Meropenem
Product NDC 81962-002
11-digit product format 819620002
Labeler code 81962
Product ID 81962-002_3877deca-080e-eeca-e063-6394a90a691a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meropenem
Dosage form INJECTION
Route INTRAVENOUS
Labeler BROOKS STERISCIENCE LIMITED
Application ANDA219084
Marketing category ANDA
Marketing start 2025-06-27
Substance MEROPENEM ANHYDROUS
Active strength 2 g/1
Pharmacologic classes Carbapenems [CS], Penem Antibacterial [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 A219084-001 MEROPENEM MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS AP 2025-06-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219084-001 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 A219084-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS AP 2025-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219084-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS AP 2025-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219084-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS AP 2025-06-23 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219084-001 MEROPENEM 2GM/VIAL POWDER / INTRAVENOUS AP 2025-06-23 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 A219084-001 AP 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219084-001 AP 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219084-001 AP 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219084-001 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Meropenem
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEROPENEM ANHYDROUS 2 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YOP6PX0BAO 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 81962-002-08 Meropenem 6 in 1 CARTON INJECTION 6 1
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 · 2 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 81962-002-08 81962000208 6 INJECTION in 1 CARTON (81962-002-08) 6 injection 2025-06-27 No No Current