FDA.reportPublic FDA data

Meropenem

Product NDC
68001-323
Requested package NDC
68001-323-31
11-digit product format
680010323
Labeler code
68001
Product ID
68001-323_45bbbbfc-a4d7-c7ed-e063-6294a90aca41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meropenem
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA205883
Marketing category
ANDA
Marketing start
2017-04-30
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68001-32368001-323-31DDiscontinued by firm2026-07-31

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
A205883-001MEROPENEMMEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2016-04-12
A205883-002MEROPENEMMEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2016-04-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205883-001AP
A205883-002AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A205883-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2016-04-12a50c72e98297…
2026-08-01 22:54:322026-06A205883-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2016-04-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205883-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A205883-002AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MeropenemMEROPENEMBluePoint Laboratoriesca5f501c-6520-4d09-aae2-4f5db74d468f2025-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205883
application number: ANDA205883
ndc (package): 68001-323-31
ndc (product): 68001-323
ndc11 (package): 68001032331
MeropenemMEROPENEMAmneal Pharmaceuticals LLCa456013b-b20e-4b29-b2f9-06f18f1ea6bd2025-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205883
application number: ANDA205883

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEROPENEM500 mg/20mL

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
ca5f501c-6520-4d09-aae2-4f5db74d468fAvailable 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
68001-323-29Meropenem20 mL in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION207
68001-323-31Meropenem10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-323-29EA - Each68001-323579d1b0f-a272-4dc5-8dfd-7e24d8a7b23412017-07-07
68001-323-31EA - Each68001-3233d3941d3-627e-4077-8a4b-56084935493112017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-323MEROPENEM INJECTION, POWDER, FOR SOLUTION [BLUEPOINT LABORATORIES]6Current NDC, Legacy NDC, 2 package rows20191023_ca5f501c-6520-4d09-aae2-4f5db74d468f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722939meropenem 1 GM InjectionPSNca5f501c-6520-4d09-aae2-4f5db74d468f7
1722934meropenem 500 MG InjectionPSNca5f501c-6520-4d09-aae2-4f5db74d468f7
1722939meropenem 1000 MG InjectionSCDca5f501c-6520-4d09-aae2-4f5db74d468f7
1722934meropenem 500 MG InjectionSCDca5f501c-6520-4d09-aae2-4f5db74d468f7
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSYca5f501c-6520-4d09-aae2-4f5db74d468f7
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSYca5f501c-6520-4d09-aae2-4f5db74d468f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-323-316800103233110 VIAL, GLASS in 1 CARTON (68001-323-31) > 20 mL in 1 VIAL, GLASS (68001-323-29) 2017-04-300000-00-00NoNoCurrent