FDA.reportPublic FDA data

NDC 43598-981-79 - Rivaroxaban

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
43598-981
Requested NDC
43598-981-79
Package NDCs from labels
43598-981-60, 43598-981-18, 43598-981-79, 43598-981-78
Manufacturer
Dr.Reddy's Laboratories, Inc. | Dr.Reddy's Laboratories Limited
Effective date
2026-04-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rivaroxaban - Dr.Reddy's Laboratories, Inc. | Dr.Reddy's Laboratories LimitedDr.Reddy's Laboratories, Inc. | Dr.Reddy's Laboratories Limited2026-04-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-981-18Rivaroxaban180 in 1 BOTTLETABLET18011
43598-981-60Rivaroxaban60 in 1 BOTTLETABLET6011
43598-981-78Rivaroxaban10 in 1 CARTONTABLET1011
43598-981-79Rivaroxaban10 in 1 BLISTER PACKTABLET1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-981RIVAROXABAN TABLET [DR.REDDY'S LABORATORIES, INC.]9Current NDC, 4 package rows20250515_122e6f78-067b-9065-adb2-ec7fec9f008e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-981-18EA - Each43598-981bf57701e-24b8-4e5a-af0e-4a878f13e7b812025-06-13
43598-981-60EA - Each43598-98101a4d7e7-5f4d-48b9-97bc-421ae341e3e812025-06-13

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 9 of 109 · 2,180 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUMTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC0206c676-c24d-470e-adb2-7cb3173f37272026-05-04WarningsExact identifier
unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - TANTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC5c5aad09-9f93-4634-8db1-c67570b38b2b2026-05-04WarningsExact identifier
unii: 15FIX9V2JP
GAVILAXPOLYETHYLENE GLYCOL 3350Preferred Pharmaceuticals, Inc.21654def-5ae0-422d-961b-1fe2456af00a2026-05-04WarningsExact identifier
unii: G2M7P15E5P
Blue Lizard Sport SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories4955fa1c-789d-4f42-af75-70223310644a2026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Kids SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesba4ae906-48c0-8384-e053-2995a90afb912026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6831832a-e52e-43ea-899f-f5d44bea5a942026-04-30WarningsExact identifier
unii: 15FIX9V2JP
Tru Skin Rituals SPF 25TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilf725cd5c-999e-2393-e053-6394a90a09dc2026-04-30WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509cad98-0321-2a0a-e063-6294a90a6ea92026-04-29WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509d7206-0cc1-c997-e063-6294a90a89e02026-04-29WarningsExact identifier
unii: 15FIX9V2JP
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEGPNY CORP211dea04-faad-8ffc-e063-6294a90a8d682026-04-29WarningsExact identifier
unii: 15FIX9V2JP
RivaroxabanRIVAROXABANDr.Reddy's Laboratories, Inc.122e6f78-067b-9065-adb2-ec7fec9f008e2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208534
ndc (package): 43598-981-78
ndc (package): 43598-981-60
ndc (package): 43598-981-18
ndc (package): 43598-981-79
ndc (product): 43598-981
ndc11 (package): 43598098179
rxcui: 2059015
spl id: eafdf7d8-5014-31c8-daa1-09fc017f5018
spl set id: 122e6f78-067b-9065-adb2-ec7fec9f008e
unii: 9NDF7JZ4M3
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
unii: 15FIX9V2JP
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350CARDINAL HEALTH 110, LLC. DBA LEADER04cc4f2e-1725-4710-8cfb-73a6bdf52e4f2026-04-23WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Aurobindo Pharma Limitedb51f2223-8266-4d6c-bf32-58e53e73b54d2026-04-23WarningsExact identifier
unii: G2M7P15E5P
COMFORTLAXPOLYETHYLENE GLYCOL 3350Family Dollar Stores, LLC02a44a41-0039-f6ec-e063-6394a90ae6f12026-04-23WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Aurohealth LLCd3c77f3f-57aa-4e2d-88aa-731cbb22af702026-04-23WarningsExact identifier
unii: G2M7P15E5P
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
unii: 15FIX9V2JP
RivaroxabanRIVAROXABANApotex Corp.e98f6d83-5172-97a1-ee41-5d7d1d8ba2fd2026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2059015
unii: 9NDF7JZ4M3
ELROEL Pang Pang Sun Cushion S7ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.256bf56f-aefa-47ce-890c-5a3896c11b922026-04-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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