FDA.reportPublic FDA data

Contepo

Product NDC
71288-035
11-digit product format
712880035
Labeler code
71288
Product ID
71288-035_ab03fd88-8988-4165-ab2a-48a5da12c7ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fosfomycin disodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
NDA212271
Marketing category
NDA
Marketing start
2025-10-22
Substance
FOSFOMYCIN SODIUM
Active strength
6 g/1
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N212271-001CONTEPOFOSFOMYCIN DISODIUMEQ 6GM BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-10-22

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N212271-001100860062034-10-12U-43322025-11-21
N212271-00193457172034-10-27U-43322025-11-21
N212271-001115410642039-01-30U-43312025-11-21

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N212271-001NP2028-10-22
N212271-001GAIN2033-10-22

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
2026-02-19 14:30 UTC2026-02N212271-001CONTEPOEQ 6GM BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-10-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212271-001CONTEPOEQ 6GM BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-10-2231067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N212271-001CONTEPOEQ 6GM BASE/VIALPOWDER / INTRAVENOUSRLD, RS2025-10-22a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N212271-001100860062034-10-12U-43322025-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212271-00193457172034-10-27U-43322025-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212271-001115410642039-01-30U-43312025-11-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212271-001100860062034-10-12U-43322025-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212271-00193457172034-10-27U-43322025-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212271-001115410642039-01-30U-43312025-11-2131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N212271-001100860062034-10-12U-43322025-11-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N212271-00193457172034-10-27U-43322025-11-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N212271-001115410642039-01-30U-43312025-11-21a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N212271-001NP2028-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212271-001GAIN2033-10-22011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N212271-001NP2028-10-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N212271-001GAIN2033-10-22a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSFOMYCIN SODIUM6 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
97MMO19FNOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2725577Internal RxNorm lookup
2725582Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
855574f2-39f8-43bc-a3d2-79dbb578cb94Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
71a697a3-5c0d-49b7-8ae7-06ff4c989d95Product name420250128

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-035-51Contepo1 in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION110
71288-035-52Contepo12 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-035-51EA - Each71288-0353d6ea876-a427-4a44-9227-4bfba3ba496f12026-04-20
71288-035-52EA - Each71288-035dc92f02f-30d2-41bc-945b-d7adcf9ee36e12026-04-20

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ContepoFOSFOMYCIN DISODIUMMeitheal Pharmaceuticals Inc.855574f2-39f8-43bc-a3d2-79dbb578cb942025-11-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 212271
application number: NDA212271
ndc (product): 71288-035

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2725582Contepo 6 GM InjectionPSN855574f2-39f8-43bc-a3d2-79dbb578cb9410
2725577fosfomycin 6 GM InjectionPSN855574f2-39f8-43bc-a3d2-79dbb578cb9410
2725582fosfomycin 6000 MG Injection [Contepo]SBD855574f2-39f8-43bc-a3d2-79dbb578cb9410
2725577fosfomycin 6000 MG InjectionSCD855574f2-39f8-43bc-a3d2-79dbb578cb9410
2725582Contepo 6 GM InjectionSY855574f2-39f8-43bc-a3d2-79dbb578cb9410
2725582Contepo 6000 MG InjectionSY855574f2-39f8-43bc-a3d2-79dbb578cb9410
2725577fosfomycin 6 GM InjectionSY855574f2-39f8-43bc-a3d2-79dbb578cb9410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71288-035-51712880035511 in 1 VIAL, GLASSHistorical
71288-035-527128800355212 VIAL, GLASS in 1 CARTON (71288-035-52) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (71288-035-51) 2025-10-22NoNoCurrent