FDA.reportPublic FDA data

rivaroxaban granule

Product NDC
70748-355
11-digit product format
707480355
Labeler code
70748
Product ID
70748-355_75d51b1e-1d97-40c7-854e-4736e335e048
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rivaroxaban granule
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA218195
Marketing category
ANDA
Marketing start
2025-09-29
Substance
RIVAROXABAN
Active strength
155 mg/1
Pharmacologic classes
Factor Xa Inhibitor [EPC], Factor Xa 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 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
A218195-001RIVAROXABANRIVAROXABAN1MG/MLFOR SUSPENSION / ORALAB2025-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218195-001AB

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
2026-08-18 06:07:402026-07A218195-001RIVAROXABAN1MG/MLFOR SUSPENSION / ORALAB2025-09-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218195-001RIVAROXABAN1MG/MLFOR SUSPENSION / ORALAB2025-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218195-001RIVAROXABAN1MG/MLFOR SUSPENSION / ORALAB2025-09-2531067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218195-001RIVAROXABAN1MG/MLFOR SUSPENSION / ORALAB2025-09-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A218195-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218195-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218195-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218195-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
rivaroxaban granule
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIVAROXABAN155 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9NDF7JZ4M3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2588062Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b0306b06-d8cf-48de-9e93-57d77e4e98f5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cd5c957-f63d-4ae5-a5e5-4e6830870998Product name320251209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70748-355-01rivaroxaban granule1 in 1 CARTONFOR SUSPENSION17
70748-355-01rivaroxaban granule1 in 1 BOTTLEFOR SUSPENSION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70748-355-01ML - Milliliter70748-355672b6963-49ba-4e5e-964b-dde7f093fd6812025-10-14

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
rivaroxaban granuleRIVAROXABAN GRANULELupin Pharmaceuticals, Inc.b0306b06-d8cf-48de-9e93-57d77e4e98f52026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218195
application number: ANDA218195
ndc (product): 70748-355

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2588062rivaroxaban 1 MG/mL Oral SuspensionPSNb0306b06-d8cf-48de-9e93-57d77e4e98f57
2588062rivaroxaban 1 MG/ML Oral SuspensionSCDb0306b06-d8cf-48de-9e93-57d77e4e98f57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70748-355-01707480355011 BOTTLE in 1 CARTON (70748-355-01) / 1 FOR SUSPENSION in 1 BOTTLE1 bottle2025-09-29NoNoCurrent