Home NDC 0143-9431 Meropenem
Product NDC 0143-9431
11-digit product format 001439431
Labeler code 0143
Product ID 0143-9431_9f2a2947-434c-4f43-aef4-b914cd862815
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meropenem
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA216424
Marketing category ANDA
Marketing start 2024-09-01
Substance MEROPENEM
Active strength 1 g/30mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216424-001 MEROPENEM MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2024-07-22 A216424-002 MEROPENEM MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2024-07-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A216424-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2024-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216424-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2024-07-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216424-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2024-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216424-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2024-07-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216424-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2024-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216424-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2024-07-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216424-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2024-07-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216424-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2024-07-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216424-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2024-07-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216424-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2024-07-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216424-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2024-07-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216424-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2024-07-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216424-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2024-07-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216424-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2024-07-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216424-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2024-07-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216424-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2024-07-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216424-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2024-07-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216424-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2024-07-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216424-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2024-07-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216424-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2024-07-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216424-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2024-07-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216424-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2024-07-22 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216424-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2024-07-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216424-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2024-07-22 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Meropenem
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEROPENEM 1 g/30mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1722934 Internal RxNorm lookup 1722939 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 0143-9431-01 Meropenem 30 mL in 1 VIAL INJECTION 30 5 0143-9431-10 Meropenem 10 in 1 CARTON INJECTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9431 MEROPENEM INJECTION [HIKMA PHARMACEUTICALS USA INC.] 5 Current NDC, 2 package rows 20250312_d54fdbad-ca93-467c-92d7-c1bd88f3bbe3.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 · 3 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 0143-9431-01 00143943101 30 mL in 1 VIAL 30 ml Historical 0143-9431-10 00143943110 10 VIAL in 1 CARTON (0143-9431-10) / 30 mL in 1 VIAL (0143-9431-01) 10 vial 2024-09-01 No No Current