FDA.reportPublic FDA data

Fosfomycin Tromethamine

Product NDC
68094-064
11-digit product format
680940064
Labeler code
68094
Product ID
68094-064_f59f5f6f-5038-436d-8ed4-fb1dfce51c1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosfomycin Tromethamine
Dosage form
GRANULE
Route
ORAL
Labeler
Precision Dose, Inc.
Application
ANDA217187
Marketing category
ANDA
Marketing start
2026-02-15
Substance
FOSFOMYCIN TROMETHAMINE
Active strength
3 g/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
A217187-001FOSFOMYCIN TROMETHAMINEFOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETFOR SOLUTION / ORALAA2025-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217187-001AA

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
2026-02-19 14:30 UTC2026-02A217187-001FOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETFOR SOLUTION / ORALAA2025-06-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217187-001FOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETFOR SOLUTION / ORALAA2025-06-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A217187-001FOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETFOR SOLUTION / ORALAA2025-06-036a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217187-001FOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETFOR SOLUTION / ORALAA2025-06-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217187-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217187-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217187-001AA16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217187-001AA1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Fosfomycin Tromethamine
Listing expiration
2027-12-31

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
f44b79d0-a789-46cb-ab70-7eb33a7debafAvailable 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
68094-064-01Fosfomycin Tromethamine1 in 1 PACKETGRANULE11
68094-064-20Fosfomycin Tromethamine1 in 1 CARTONGRANULE11

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 TROMETHAMINEPrecision Dose, Inc.f44b79d0-a789-46cb-ab70-7eb33a7debaf2025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217187
application number: ANDA217187
ndc (product): 68094-064

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808917fosfomycin 3 GM Granules for Oral SolutionPSNf44b79d0-a789-46cb-ab70-7eb33a7debaf1
808917fosfomycin 3000 MG Granules for Oral SolutionSCDf44b79d0-a789-46cb-ab70-7eb33a7debaf1
808917fosfomycin (as fosfomycin tromethamine) 3000 MG Granules for Oral SolutionSYf44b79d0-a789-46cb-ab70-7eb33a7debaf1
808917fosfomycin 3 GM Granules for Oral SolutionSYf44b79d0-a789-46cb-ab70-7eb33a7debaf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68094-064-01680940064011 in 1 PACKETHistorical
68094-064-20680940064201 PACKET in 1 CARTON (68094-064-20) / 1 GRANULE in 1 PACKET (68094-064-01) 1 packet2026-02-15NoNoCurrent