Home NDC 72572-412 Meropenem
Product NDC 72572-412
11-digit product format 725720412
Labeler code 72572
Product ID 72572-412_3e9af753-03b1-7206-e063-6294a90ad02d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meropenem
Dosage form INJECTION
Route INTRAVENOUS
Labeler Civica, Inc.
Application ANDA216154
Marketing category ANDA
Marketing start 2025-09-08
Substance MEROPENEM
Active strength 500 mg/20mL
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 A216154-001 MEROPENEM MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 A216154-002 MEROPENEM MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18
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.
Product history page 1 of 2 · 54 observed 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 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION 2022-08-18 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION 2022-08-18 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Meropenem
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEROPENEM 500 mg/20mL
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 72572-412-10 Meropenem 10 in 1 CARTON INJECTION 10 4 72572-412-10 Meropenem 20 mL in 1 VIAL INJECTION 20 4
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 72572-412-10 72572041210 10 VIAL in 1 CARTON (72572-412-10) / 20 mL in 1 VIAL 10 vial 2025-09-08 No No Current