FDA.reportPublic FDA data

ALLI

Product NDC
0135-0461
11-digit product format
001350461
Labeler code
0135
Product ID
0135-0461_4d51b8f1-a819-7ff6-e063-6294a90a82bc
Type
HUMAN OTC DRUG
Nonproprietary name
orlistat
Dosage form
CAPSULE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA021887
Marketing category
NDA
Marketing start
2007-02-07
Substance
ORLISTAT
Active strength
60 mg/1
Pharmacologic classes
Intestinal Lipase Inhibitor [EPC], Lipase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ORLISTAT60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii95M8R751W8
Rxcui692876, 723846

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b3f93084-d1af-0d2d-125b-736522e0a7a2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0461-012020-11-09C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-022020-11-09C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-032020-11-09C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-052020-11-09C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-062020-11-09C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-072020-11-09C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-082020-11-09C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-012020-01-31C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-022020-01-31C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-032020-01-31C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-052020-01-31C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-062020-01-31C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-072020-01-31C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts
0135-0461-082020-01-31C16284748780-19d75b9d0-7d53-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0461-01ALLI60 in 1 BOTTLECAPSULE6015
0135-0461-02ALLI90 in 1 BOTTLECAPSULE9015
0135-0461-03ALLI120 in 1 BOTTLECAPSULE12015
0135-0461-05ALLI120 in 1 BOTTLECAPSULE12015
0135-0461-06ALLI170 in 1 BOTTLECAPSULE17015
0135-0461-07ALLI21 in 1 BOTTLECAPSULE2115
0135-0461-08ALLI2 in 1 CARTONCAPSULE215
0135-0461-08ALLI60 in 1 BOTTLECAPSULE6015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0461-01EA - Each0135-0461060dcda2-78a0-40a4-9c3b-e21127b35e6312021-05-05
0135-0461-02EA - Each0135-0461b587d8e8-bdf7-455b-a8dd-f9538f9cf31712012-07-24
0135-0461-05EA - Each0135-046161e49d90-2834-484b-b6cb-3acf721107ed12012-07-24
0135-0461-06EA - Each0135-046162c7e670-db2d-4367-b445-42e246996c2112012-07-24
0135-0461-07EA - Each0135-046159c364d2-2aa2-497a-8993-7ff5e80e723f12024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ORLISTATACTIVE INGREDIENT95M8R751W8ALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
ORLISTATACTIVE MOIETY95M8R751W8ALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
FERROUS OXIDEINACTIVE INGREDIENTG7036X8B5HALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
GELATININACTIVE INGREDIENT2G86QN327LALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
POVIDONESINACTIVE INGREDIENTFZ989GH94EALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
TALCINACTIVE INGREDIENT7SEV7J4R1UALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLI (ORLISTAT) CAPSULE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0461ALLI (ORLISTAT) CAPSULE [HALEON US HOLDINGS LLC]14Current NDC, Legacy NDC, 8 package rows20240117_a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
723846Alli 60 MG Oral CapsulePSNa2d3bd73-f3af-4ea5-a57c-66b0004cfe4f15
692876orlistat 60 MG Oral CapsulePSNa2d3bd73-f3af-4ea5-a57c-66b0004cfe4f15
723846orlistat 60 MG Oral Capsule [Alli]SBDa2d3bd73-f3af-4ea5-a57c-66b0004cfe4f15
692876orlistat 60 MG Oral CapsuleSCDa2d3bd73-f3af-4ea5-a57c-66b0004cfe4f15
723846Alli 60 MG Oral CapsuleSYa2d3bd73-f3af-4ea5-a57c-66b0004cfe4f15
723846Alli 60 MG Oral CapsulePSN14a75092-f910-53df-e063-6294a90acc661
692876orlistat 60 MG Oral CapsulePSN14a75092-f910-53df-e063-6294a90acc661
723846orlistat 60 MG Oral Capsule [Alli]SBD14a75092-f910-53df-e063-6294a90acc661
692876orlistat 60 MG Oral CapsuleSCD14a75092-f910-53df-e063-6294a90acc661
723846Alli 60 MG Oral CapsuleSY14a75092-f910-53df-e063-6294a90acc661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0461-010013504610160 CAPSULE in 1 BOTTLE (0135-0461-01) 60 capsule2016-09-010000-00-00NoNoCurrent
0135-0461-020013504610290 CAPSULE in 1 BOTTLE (0135-0461-02) 90 capsule2007-02-070000-00-00NoNoCurrent
0135-0461-0300135046103120 CAPSULE in 1 BOTTLE (0135-0461-03) 120 capsule2007-02-070000-00-00NoNoCurrent
0135-0461-0500135046105120 CAPSULE in 1 BOTTLE (0135-0461-05) 120 capsule2007-02-070000-00-00NoNoCurrent
0135-0461-0600135046106170 CAPSULE in 1 BOTTLE (0135-0461-06) 170 capsule2007-02-070000-00-00NoNoCurrent
0135-0461-070013504610721 CAPSULE in 1 BOTTLE (0135-0461-07) 21 capsule2007-02-070000-00-00NoNoCurrent
0135-0461-08001350461082 BOTTLE in 1 CARTON (0135-0461-08) > 60 CAPSULE in 1 BOTTLE2 bottle2007-02-070000-00-00NoNoCurrent