FDA.reportPublic FDA data

OSELTAMIVIR PHOSPHATE

Product NDC
62332-769
Requested package NDC
62332-769-60
11-digit product format
623320769
Labeler code
62332
Product ID
62332-769_4e042ec2-3d42-4354-88d7-cefe8f4a4840
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OSELTAMIVIR PHOSPHATE
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA218307
Marketing category
ANDA
Marketing start
2026-06-29
Substance
OSELTAMIVIR PHOSPHATE
Active strength
6 mg/mL
Pharmacologic classes
Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
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 43.

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
A218307-001OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2026-06-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218307-001AB

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
2026-09-14 22:38:342026-08A218307-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2026-06-2584e616aacf4f…
2026-08-18 06:07:402026-07A218307-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2026-06-25caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218307-001OSELTAMIVIR PHOSPHATEEQ 6MG BASE/MLFOR SUSPENSION / ORALAB2026-06-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218307-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A218307-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218307-001AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
OSELTAMIVIR PHOSPHATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OSELTAMIVIR PHOSPHATE6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4A3O49NGEZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1115698Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
379f59fe-22d9-4bac-b9b5-31fdaebbd923Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEAlembic Pharmaceuticals Inc.379f59fe-22d9-4bac-b9b5-31fdaebbd9232026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218307
application number: ANDA218307
ndc (package): 62332-769-60
ndc (product): 62332-769
ndc11 (package): 62332076960
OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEAlembic Pharmaceuticals Limiteda70d9914-078f-4b4d-a1be-04669f7d08782026-03-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218307
application number: ANDA218307

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-769-60623320769601 BOTTLE, PLASTIC in 1 CARTON (62332-769-60) / 60 mL in 1 BOTTLE, PLASTIC2026-06-29NoNoCurrent