FDA.reportPublic FDA data

Fosfomycin tromethamine

Product NDC
59651-651
11-digit product format
596510651
Labeler code
59651
Product ID
59651-651_f8ec4771-3f8d-473a-a1d0-e42038f61a42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosfomycin tromethamine
Dosage form
GRANULE, FOR SOLUTION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA217608
Marketing category
ANDA
Marketing start
2025-11-14
Substance
FOSFOMYCIN TROMETHAMINE
Active strength
3 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 42.

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
A217608-001FOSFOMYCIN TROMETHAMINEFOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETFOR SOLUTION / ORALAA2025-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217608-001AA

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
2026-08-18 06:07:402026-07A217608-001FOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETFOR SOLUTION / ORALAA2025-11-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217608-001FOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETFOR SOLUTION / ORALAA2025-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217608-001FOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETFOR SOLUTION / ORALAA2025-11-1431067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217608-001FOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETFOR SOLUTION / ORALAA2025-11-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217608-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217608-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217608-001AA131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217608-001AA1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSFOMYCIN TROMETHAMINE3 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7FXW6U30GYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
808917Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f8ec4771-3f8d-473a-a1d0-e42038f61a42Available 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
59651-651-03Fosfomycin tromethamine1 in 1 CARTONGRANULE, FOR SOLUTION11
59651-651-03Fosfomycin tromethamine1 in 1 PACKETGRANULE, FOR SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-651-03EA - Each59651-65148eb3f6a-972e-4ac2-a5f9-525ac0535fba12026-01-08

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
Fosfomycin tromethamineFOSFOMYCIN TROMETHAMINEAurobindo Pharma Limitedf8ec4771-3f8d-473a-a1d0-e42038f61a422025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217608
application number: ANDA217608
ndc (product): 59651-651

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808917fosfomycin 3 GM Granules for Oral SolutionPSNf8ec4771-3f8d-473a-a1d0-e42038f61a421
808917fosfomycin 3000 MG Granules for Oral SolutionSCDf8ec4771-3f8d-473a-a1d0-e42038f61a421
808917fosfomycin (as fosfomycin tromethamine) 3000 MG Granules for Oral SolutionSYf8ec4771-3f8d-473a-a1d0-e42038f61a421
808917fosfomycin 3 GM Granules for Oral SolutionSYf8ec4771-3f8d-473a-a1d0-e42038f61a421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-651-03596510651031 PACKET in 1 CARTON (59651-651-03) / 1 GRANULE, FOR SOLUTION in 1 PACKET1 packet2025-11-14NoNoCurrent