FDA.reportPublic FDA data

MEROPENEM

Product NDC
70594-075
Requested package NDC
70594-075-02
11-digit product format
705940075
Labeler code
70594
Product ID
70594-075_3ee484ef-4e7f-464a-ac2e-7963d9dc5df6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MEROPENEM
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Xellia Pharmaceuticals USA LLC
Application
ANDA206141
Marketing category
ANDA
Marketing start
2021-06-28
Substance
MEROPENEM
Active strength
500 mg/1
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
A206141-001MEROPENEMMEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2016-06-08
A206141-002MEROPENEMMEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2016-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206141-001AP
A206141-002AP

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 22:54:322026-06A206141-001MEROPENEM500MG/VIALINJECTABLE / INJECTIONAP2016-06-08a50c72e98297…
2026-08-01 22:54:322026-06A206141-002MEROPENEM1GM/VIALINJECTABLE / INJECTIONAP2016-06-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206141-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A206141-002AP1a50c72e98297…

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
MeropenemMEROPENEMGland Pharma Limited4e4e2c0c-df54-4229-ab90-fa671ecedd572025-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206141
application number: ANDA206141
MEROPENEMMEROPENEMXellia Pharmaceuticals USA LLC06d84c55-94ff-46e5-8477-b8881c12eb0a2024-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206141
application number: ANDA206141
ndc (package): 70594-075-02
ndc (product): 70594-075
ndc11 (package): 70594007502

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEROPENEM500 mg/1

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
06d84c55-94ff-46e5-8477-b8881c12eb0aAvailable 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
70594-075-01MEROPENEM1 in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION17
70594-075-02MEROPENEM10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-075-01EA - Each70594-0756b66b112-d7e1-45e3-9ecd-f451e089876d12021-09-07
70594-075-02EA - Each70594-07506584bf5-011f-40ee-97f3-0eff9f3e1faf12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-075MEROPENEM INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]7Current NDC, Legacy NDC, 2 package rows20241211_06d84c55-94ff-46e5-8477-b8881c12eb0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1722939meropenem 1 GM InjectionPSN06d84c55-94ff-46e5-8477-b8881c12eb0a7
1722934meropenem 500 MG InjectionPSN06d84c55-94ff-46e5-8477-b8881c12eb0a7
1722939meropenem 1000 MG InjectionSCD06d84c55-94ff-46e5-8477-b8881c12eb0a7
1722934meropenem 500 MG InjectionSCD06d84c55-94ff-46e5-8477-b8881c12eb0a7
1722939meropenem (as meropenem trihydrate) 1000 MG InjectionSY06d84c55-94ff-46e5-8477-b8881c12eb0a7
1722934meropenem (as meropenem trihydrate) 500 MG InjectionSY06d84c55-94ff-46e5-8477-b8881c12eb0a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70594-075-027059400750210 VIAL, GLASS in 1 CARTON (70594-075-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (70594-075-01) 2021-06-280000-00-00NoNoCurrent