Home NDC 0143-9486 Meropenem
Product NDC 0143-9486
11-digit product format 001439486
Labeler code 0143
Product ID 0143-9486_c7a35300-aec1-427b-a7d1-3856ee841c45
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Meropenem
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA210773
Marketing category ANDA
Marketing start 2026-06-08
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 43 .
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 A210773-001 MEROPENEM MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 A210773-002 MEROPENEM MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16
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 3 · 84 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 2026-09-14 22:38:34 2026-08 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210773-001 MEROPENEM 500MG/VIAL INJECTABLE / INJECTION AP 2019-08-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210773-002 MEROPENEM 1GM/VIAL INJECTABLE / INJECTION AP 2019-08-16 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0143-9486-10 00143948610 10 VIAL in 1 CARTON (0143-9486-10) / 20 mL in 1 VIAL (0143-9486-01) 10 vial 2026-06-08 No No Current