FDA.reportPublic FDA data

Fosfomycin Tromethamine

Product NDC
63629-9470
Requested package NDC
63629-9470-1
11-digit product format
636299470
Labeler code
63629
Product ID
63629-9470_a06194fb-7c70-4b28-b8bf-e1525a97bc10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosfomycin Tromethamine
Dosage form
GRANULE, FOR SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214554
Marketing category
ANDA
Marketing start
2021-10-22
Marketing end
0000-00-00
Substance
FOSFOMYCIN TROMETHAMINE
Active strength
3 g/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage63629-947063629-9470-1DDiscontinued 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214554-001FOSFOMYCIN TROMETHAMINEFOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETFOR SOLUTION / ORALAA2021-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214554-001AA

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
2026-08-01 22:54:322026-06A214554-001FOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKETFOR SOLUTION / ORALAA2021-10-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214554-001AA1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fosfomycin TromethamineFOSFOMYCIN TROMETHAMINEAscend Laboratories, LLC48e352bc-52ea-4778-905a-60ef38a5c18a2025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214554
application number: ANDA214554
Fosfomycin TromethamineFOSFOMYCIN TROMETHAMINEKesin Pharma Corporation3fa61bd4-fc55-0987-e063-6394a90abce22025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214554
application number: ANDA214554
Fosfomycin TromethamineFOSFOMYCIN TROMETHAMINEA-S Medication Solutions6b9167a9-80e9-44e1-a609-c3eb78960acf2023-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214554
application number: ANDA214554

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9470-1EA - Each63629-9470601b4fb4-90eb-4c62-b0b6-1009e94ab28112023-01-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9470-1636299470011 PACKET in 1 CARTON (63629-9470-1) > 1 GRANULE, FOR SOLUTION in 1 PACKET1 packet2022-11-280000-00-00NoNoCurrent