Meropenem

Product NDC
63323-507
11-digit product format
633230507
Labeler code
63323
Product ID
63323-507_6e7f961a-7766-4426-8aa4-096bfba99e56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meropenem
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA091404
Marketing category
ANDA
Marketing start
2011-10-14
Substance
MEROPENEM
Active strength
500 mg/10mL
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091404-001MEROPENEMMEROPENEM500MG/VIALINJECTABLE / INJECTIONAPRS2011-10-26
A091404-002MEROPENEMMEROPENEM1GM/VIALINJECTABLE / INJECTIONAPRS2011-10-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A091404-001AP
A091404-002AP

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAPRS2011-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAPRS2011-10-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAPRS2011-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAPRS2011-10-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAPRS2011-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAPRS2011-10-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2011-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2011-10-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2011-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2011-10-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2011-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2011-10-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2011-10-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2011-10-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2011-10-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2011-10-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2011-10-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2011-10-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2011-10-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2011-10-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2011-10-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2011-10-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2011-10-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2011-10-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2011-10-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2011-10-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2011-10-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2011-10-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2011-10-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2011-10-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2011-10-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2011-10-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2011-10-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2011-10-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2011-10-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2011-10-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2011-10-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2011-10-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091404-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2011-10-26782e0a99824c…
2021-12-28 21:50 UTC2021-12A091404-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2011-10-26782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091404-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091404-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091404-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091404-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091404-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091404-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091404-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091404-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091404-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091404-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091404-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091404-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091404-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091404-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091404-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091404-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091404-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091404-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091404-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091404-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091404-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091404-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091404-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091404-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091404-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091404-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091404-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091404-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091404-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091404-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091404-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091404-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091404-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091404-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091404-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091404-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091404-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091404-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091404-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091404-002AP1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Meropenem
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEROPENEM500 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FV9J3JU8B1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1722934Internal RxNorm lookup
1722939Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
12714f80-d6e5-4453-b66c-62f57c16ddfcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
437602ae-8b0a-4f4e-8f97-eabd2e27845eProduct name620250305
407c0246-8bda-450d-8667-f622a350d05cProduct name120231023
b1a98f8c-7b20-4bc2-b772-289c5d0949a9Product name120171106
940e5686-419d-4429-a15d-7bf46e26b176Product name120150929

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-507-19Meropenem10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION1016
63323-507-21Meropenem10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1016
63323-507-01Meropenem10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION1015
63323-507-20Meropenem10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1015
63323-507-25Meropenem25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION2511
63323-507-43Meropenem10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-507-01EA - Each63323-507321fad89-ec91-4ad9-b2ac-997a43e0700012022-02-07
63323-507-19EA - Each63323-5076a7006db-9032-4cd3-b56e-f212b63a972312026-02-05
63323-507-20EA - Each63323-507f953ac5f-8c3d-4763-872a-d6ddb14d6a0f12012-07-24
63323-507-21EA - Each63323-5079009ebdc-77de-4985-9030-c0d4ae27872812013-03-03
63323-507-25EA - Each63323-5072e82be56-fe76-48de-8880-577c544c7e5b12015-01-05

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-507MEROPENEM (MEROPENEM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC ]16Current NDC, Legacy NDC, 2 package rows20210317_12714f80-d6e5-4453-b66c-62f57c16ddfc.zip
63323-507MEROPENEM (MEROPENEM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC ]15Current NDC, Legacy NDC, 2 package rows20210310_185181e3-c004-4d61-b992-5df94fe57a90.zip
63323-507MEROPENEM (MEROPENEM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]11Current NDC, Legacy NDC, 2 package rows20210316_7a68d899-2678-43a9-a9c1-ef8f916b562f.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MeropenemMEROPENEMHospira, Inc.e9b6555f-20a1-4415-bb80-3d034cfab95b2024-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091404
application number: ANDA091404
MeropenemMEROPENEMHospira, Inc.092ebd9b-77a0-4877-afc3-dd8211730f712024-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091404
application number: ANDA091404
MeropenemMEROPENEMFresenius Kabi USA, LLC12714f80-d6e5-4453-b66c-62f57c16ddfc2021-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091404
application number: ANDA091404
ndc (product): 63323-507
MeropenemMEROPENEMFresenius Kabi USA, LLC7a68d899-2678-43a9-a9c1-ef8f916b562f2021-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091404
application number: ANDA091404
ndc (product): 63323-507
MeropenemMEROPENEMFresenius Kabi USA, LLC185181e3-c004-4d61-b992-5df94fe57a902020-10-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091404
application number: ANDA091404
ndc (product): 63323-507

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722939meropenem 1 GM InjectionPSN12714f80-d6e5-4453-b66c-62f57c16ddfc16
1722934meropenem 500 MG InjectionPSN12714f80-d6e5-4453-b66c-62f57c16ddfc16
1722939meropenem 1000 MG InjectionSCD12714f80-d6e5-4453-b66c-62f57c16ddfc16
1722934meropenem 500 MG InjectionSCD12714f80-d6e5-4453-b66c-62f57c16ddfc16
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSY12714f80-d6e5-4453-b66c-62f57c16ddfc16
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSY12714f80-d6e5-4453-b66c-62f57c16ddfc16
1722939meropenem 1 GM InjectionPSN185181e3-c004-4d61-b992-5df94fe57a9015
1722934meropenem 500 MG InjectionPSN185181e3-c004-4d61-b992-5df94fe57a9015
1722939meropenem 1000 MG InjectionSCD185181e3-c004-4d61-b992-5df94fe57a9015
1722934meropenem 500 MG InjectionSCD185181e3-c004-4d61-b992-5df94fe57a9015
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSY185181e3-c004-4d61-b992-5df94fe57a9015
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSY185181e3-c004-4d61-b992-5df94fe57a9015
1722939meropenem 1 GM InjectionPSN7a68d899-2678-43a9-a9c1-ef8f916b562f11
1722934meropenem 500 MG InjectionPSN7a68d899-2678-43a9-a9c1-ef8f916b562f11
1722939meropenem 1000 MG InjectionSCD7a68d899-2678-43a9-a9c1-ef8f916b562f11
1722934meropenem 500 MG InjectionSCD7a68d899-2678-43a9-a9c1-ef8f916b562f11
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSY7a68d899-2678-43a9-a9c1-ef8f916b562f11
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSY7a68d899-2678-43a9-a9c1-ef8f916b562f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-507-016332305070110 mL in 1 VIAL10 mlHistorical
63323-507-196332305071910 mL in 1 VIAL10 mlHistorical
63323-507-206332305072010 VIAL in 1 CARTON (63323-507-20) / 10 mL in 1 VIAL (63323-507-01) 10 vial2011-10-140000-00-00NoNoCurrent
63323-507-216332305072110 VIAL in 1 CARTON (63323-507-21) / 10 mL in 1 VIAL (63323-507-19) 10 vial2011-10-140000-00-00NoNoCurrent
63323-507-256332305072525 VIAL in 1 CARTON (63323-507-25) / 10 mL in 1 VIAL (63323-507-43) 25 vial2011-10-140000-00-00NoNoCurrent
63323-507-436332305074310 mL in 1 VIAL10 mlHistorical