Oseltamivir phosphate

Product NDC
68180-677
11-digit product format
681800677
Labeler code
68180
Product ID
68180-677_d28b6190-f009-485f-905e-63f7a22fb68c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oseltamivir phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA208348
Marketing category
ANDA
Marketing start
2018-02-09
Substance
OSELTAMIVIR PHOSPHATE
Active strength
75 mg/1
Pharmacologic classes
Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208348-001OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-09
A208348-002OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-09
A208348-003OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A208348-001AB
A208348-002AB
A208348-003AB

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208348-002OSELTAMIVIR PHOSPHATEEQ 45MG BASECAPSULE / ORALAB2018-01-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208348-003OSELTAMIVIR PHOSPHATEEQ 75MG BASECAPSULE / ORALAB2018-01-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208348-001OSELTAMIVIR PHOSPHATEEQ 30MG BASECAPSULE / ORALAB2018-01-098072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208348-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208348-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208348-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208348-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208348-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208348-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208348-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208348-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208348-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208348-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208348-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208348-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208348-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208348-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208348-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208348-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208348-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208348-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208348-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208348-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208348-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208348-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208348-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208348-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208348-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208348-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208348-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208348-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208348-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208348-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208348-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208348-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208348-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208348-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208348-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208348-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208348-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208348-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208348-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208348-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OSELTAMIVIR PHOSPHATE75 mg/1

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312122Internal RxNorm lookup
728109Internal RxNorm lookup
728113Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7dd9f7f2-a887-454a-8d3e-761083b840dbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6022fcc-885e-41f7-971c-fe19ade5d9baProduct name920190926

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-677-10Oseltamivir phosphate10 in 1 BOTTLECAPSULE1014
68180-677-11Oseltamivir phosphate1 in 1 CARTONCAPSULE114
68180-677-11Oseltamivir phosphate10 in 1 BLISTER PACKCAPSULE1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-677-11EA - Each68180-677c583c3e7-04a6-4a74-ad56-2beace0beb8212018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-677OSELTAMIVIR PHOSPHATE CAPSULE [LUPIN PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 3 package rows20250206_7dd9f7f2-a887-454a-8d3e-761083b840db.zip

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oseltamivir phosphateOSELTAMIVIR PHOSPHATEREMEDYREPACK INC.ad765459-e0d2-418e-8bae-8f6d16dfc1d82026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208348
application number: ANDA208348
Oseltamivir phosphateOSELTAMIVIR PHOSPHATELupin Pharmaceuticals, Inc.7dd9f7f2-a887-454a-8d3e-761083b840db2025-10-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208348
application number: ANDA208348
ndc (product): 68180-677
Oseltamivir phosphateOSELTAMIVIR PHOSPHATEPreferred Pharmaceuticals Inc.40312c99-5374-41fa-a687-c70d97445e242025-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208348
application number: ANDA208348
Oseltamivir phosphateOSELTAMIVIR PHOSPHATEProficient Rx LPcd0236c6-317c-47b1-9185-3253dba4bb372022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208348
application number: ANDA208348
Oseltamivir phosphateOSELTAMIVIR PHOSPHATEProficient Rx LP196c8dee-342b-4627-b060-39b99ed91a412022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208348
application number: ANDA208348

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728109oseltamivir phosphate 30 MG Oral CapsulePSN7dd9f7f2-a887-454a-8d3e-761083b840db14
728113oseltamivir phosphate 45 MG Oral CapsulePSN7dd9f7f2-a887-454a-8d3e-761083b840db14
312122oseltamivir phosphate 75 MG Oral CapsulePSN7dd9f7f2-a887-454a-8d3e-761083b840db14
728109oseltamivir 30 MG Oral CapsuleSCD7dd9f7f2-a887-454a-8d3e-761083b840db14
728113oseltamivir 45 MG Oral CapsuleSCD7dd9f7f2-a887-454a-8d3e-761083b840db14
312122oseltamivir 75 MG Oral CapsuleSCD7dd9f7f2-a887-454a-8d3e-761083b840db14
728109oseltamivir (as oseltamivir phosphate) 30 MG Oral CapsuleSY7dd9f7f2-a887-454a-8d3e-761083b840db14
728113oseltamivir (as oseltamivir phosphate) 45 MG Oral CapsuleSY7dd9f7f2-a887-454a-8d3e-761083b840db14
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY7dd9f7f2-a887-454a-8d3e-761083b840db14
312122oseltamivir phosphate 75 MG Oral CapsulePSNcd0236c6-317c-47b1-9185-3253dba4bb374
312122oseltamivir phosphate 75 MG Oral CapsulePSNad765459-e0d2-418e-8bae-8f6d16dfc1d84
312122oseltamivir 75 MG Oral CapsuleSCDcd0236c6-317c-47b1-9185-3253dba4bb374
312122oseltamivir 75 MG Oral CapsuleSCDad765459-e0d2-418e-8bae-8f6d16dfc1d84
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYcd0236c6-317c-47b1-9185-3253dba4bb374
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSYad765459-e0d2-418e-8bae-8f6d16dfc1d84
312122oseltamivir phosphate 75 MG Oral CapsulePSN40312c99-5374-41fa-a687-c70d97445e241
312122oseltamivir phosphate 75 MG Oral CapsulePSN1f3ed814-7243-6581-e063-6394a90a40851
312122oseltamivir 75 MG Oral CapsuleSCD40312c99-5374-41fa-a687-c70d97445e241
312122oseltamivir 75 MG Oral CapsuleSCD1f3ed814-7243-6581-e063-6394a90a40851
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY40312c99-5374-41fa-a687-c70d97445e241
312122oseltamivir (as oseltamivir phosphate) 75 MG Oral CapsuleSY1f3ed814-7243-6581-e063-6394a90a40851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-677-106818006771010 CAPSULE in 1 BOTTLE (68180-677-10) 10 capsule2018-02-090000-00-00NoNoCurrent
68180-677-11681800677111 BLISTER PACK in 1 CARTON (68180-677-11) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2018-02-090000-00-00NoNoCurrent