Meropenem

Product NDC
70278-103
11-digit product format
702780103
Labeler code
70278
Product ID
70278-103_eed23a09-bc93-c40b-e053-2a95a90a4a1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meropenem
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Daewoong America Inc.
Application
ANDA204854
Marketing category
ANDA
Marketing start
2016-10-08
Marketing end
0000-00-00
Substance
MEROPENEM
Active strength
500 mg/20mL
Pharmacologic classes
Carbapenems [CS], Penem Antibacterial [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70278-103DDiscontinued by firm2026-10-16
excluded packagepackage70278-10370278-103-02DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70278-103-02DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70278-103-02DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70278-103-02DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70278-103-02DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70278-103-02DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70278-103-02DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70278-103-02DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70278-103-02DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70278-103-02DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70278-103-02DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70278-103-02DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70278-103-02DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70278-103-02IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70278-103-02IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70278-103-02IInactivated by FDA1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204854-001MEROPENEMMEROPENEM500MG/VIALINJECTABLE / INJECTION2015-12-18
A204854-002MEROPENEMMEROPENEM1GM/VIALINJECTABLE / INJECTION2015-12-18

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTION2015-12-18c2088c7a36db…
2026-10-15 13:18:302026-09A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTION2015-12-18c2088c7a36db…
2026-09-14 22:38:342026-08A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTION2015-12-1884e616aacf4f…
2026-09-14 22:38:342026-08A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTION2015-12-1884e616aacf4f…
2026-08-18 06:07:402026-07A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTION2015-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTION2015-12-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTION2015-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTION2015-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTION2015-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTION2015-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTION2015-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTION2015-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTION2015-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTION2015-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTION2015-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTION2015-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTION2015-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTION2015-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTION2015-12-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTION2015-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTION2015-12-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTION2015-12-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTION2015-12-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTION2015-12-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTION2015-12-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTION2015-12-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTION2015-12-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTION2015-12-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTION2015-12-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTION2015-12-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTION2015-12-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTION2015-12-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTION2015-12-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTION2015-12-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2015-12-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2015-12-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2015-12-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2015-12-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204854-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2015-12-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204854-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2015-12-184b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-01-26 05:58 UTC2023-01A204854-001AP13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A204854-002AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204854-001AP13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204854-002AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204854-001AP1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A204854-002AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204854-001AP1e64feba35796…
2022-09-29 23:25 UTC2022-09A204854-002AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204854-001AP1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204854-002AP1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70278-103-027027801030210 VIAL in 1 CARTON (70278-103-02) > 20 mL in 1 VIAL (70278-103-01) 10 vial2016-10-080000-00-00NoNoCurrent