Home NDC 81962-001 Meropenem
Product NDC 81962-001
11-digit product format 819620001
Labeler code 81962
Product ID 81962-001_4caa1d3a-1dba-7392-e063-6294a90a0080
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meropenem
Dosage form INJECTION
Route INTRAVENOUS
Labeler BROOKS STERISCIENCE LIMITED
Application ANDA216154
Marketing category ANDA
Marketing start 2023-05-31
Substance MEROPENEM
Active strength 1 g/20mL
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 42 .
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 · 56 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 2026-08-18 06:07:40 2026-07 A216154-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2022-08-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216154-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2022-08-18 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 50 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Meropenem
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEROPENEM 1 g/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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81962-001 MEROPENEM INJECTION [BROOKS STERISCIENCE LIMITED] 9 Current NDC, Legacy NDC, 6 package rows 20250125_58e165b7-e230-4459-abf9-06d5ca1dd7b2.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 Marketing end Sample Exclude flag Status 81962-001-01 81962000101 1 VIAL in 1 CARTON (81962-001-01) / 20 mL in 1 VIAL 1 vial 2023-05-31 0000-00-00 No No Current 81962-001-02 81962000102 10 VIAL in 1 CARTON (81962-001-02) / 20 mL in 1 VIAL 10 vial 2023-05-31 0000-00-00 No No Current 81962-001-03 81962000103 25 VIAL in 1 CARTON (81962-001-03) / 20 mL in 1 VIAL 25 vial 2023-05-31 0000-00-00 No No Current