FDA.reportPublic FDA data

Lansoprazole

Product NDC
55111-399
11-digit product format
551110399
Labeler code
55111
Product ID
55111-399_c8eb1d41-1fd2-7c06-486c-e6abf08faa6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Dr.Reddy's Laboratories Ltd.
Application
ANDA091269
Marketing category
ANDA
Marketing start
2010-10-15
Substance
LANSOPRAZOLE
Active strength
30 mg/1
Pharmacologic classes
Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui311277, 596843

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-399-01Lansoprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10028
55111-399-05Lansoprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE50028
55111-399-30Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3028
55111-399-60Lansoprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE6028
55111-399-79Lansoprazole1 in 1 CARTONCAPSULE, DELAYED RELEASE128
55111-399-79Lansoprazole10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1028
55111-399-90Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-399-05EA - Each55111-3995789f747-2be5-4d78-b312-d232fa06adae12012-07-24
55111-399-30EA - Each55111-399cf6f17c1-f3d9-483a-a3c0-64a79eb71a3612025-12-16
55111-399-90EA - Each55111-3997ba47122-fa18-4882-8098-99bdc8681d9a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
lansoprazoleACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
lansoprazoleACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
ammoniaINACTIVE INGREDIENT5138Q19F1XLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
ferric oxide redINACTIVE INGREDIENT1K09F3G675LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
gelatinINACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
hydroxypropyl cellulose, low substitutedINACTIVE INGREDIENT2165RE0K14LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
magnesium carbonateINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
methacrylic acid - ethyl acrylate copolymer (1:1) Type AINACTIVE INGREDIENTNX76LV5T8JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
raw sugarINACTIVE INGREDIENT8M707QY5GHLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
shellacINACTIVE INGREDIENT46N107B71OLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
starch, cornINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
sucroseINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
talcINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]18
lansoprazoleACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
lansoprazoleACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
ammoniaINACTIVE INGREDIENT5138Q19F1XLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
gelatinINACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
hydroxypropyl cellulose, low substitutedINACTIVE INGREDIENT2165RE0K14LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
magnesium carbonateINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
methacrylic acid - ethyl acrylate copolymer (1:1) Type AINACTIVE INGREDIENTNX76LV5T8JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
RAW SUGARINACTIVE INGREDIENT8M707QY5GHLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
raw sugarINACTIVE INGREDIENT8M707QY5GHLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
shellacINACTIVE INGREDIENT46N107B71OLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
SHELLACINACTIVE INGREDIENT46N107B71OLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
starch, cornINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
sucroseINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
SUCROSEINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1
talcINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-399LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR.REDDY'S LABORATORIES LTD.]28Current NDC, Legacy NDC, 7 package rows20220525_82174fcc-1b0f-2068-7fc4-db335b43b5e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNc3928dfc-c10b-456c-8826-f1a7956142ed101
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDc3928dfc-c10b-456c-8826-f1a7956142ed101
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN82174fcc-1b0f-2068-7fc4-db335b43b5e228
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN82174fcc-1b0f-2068-7fc4-db335b43b5e228
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD82174fcc-1b0f-2068-7fc4-db335b43b5e228
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD82174fcc-1b0f-2068-7fc4-db335b43b5e228
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN12b2e59b-2b7a-4d22-ad9b-9a7d9a5264bd16
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD12b2e59b-2b7a-4d22-ad9b-9a7d9a5264bd16
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN854e4235-4815-4461-9b9b-d3d783fb775d6
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD854e4235-4815-4461-9b9b-d3d783fb775d6
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN3e3e63df-e2ad-420b-acb9-28e65ea6fb074
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD3e3e63df-e2ad-420b-acb9-28e65ea6fb074
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN90a529d4-9406-4b5a-e053-2995a90aff211
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNccc1b1ae-f9f1-4d0d-90eb-38f7812688931
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD90a529d4-9406-4b5a-e053-2995a90aff211
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDccc1b1ae-f9f1-4d0d-90eb-38f7812688931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-399-0155111039901100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-399-01) 2010-10-150000-00-00NoNoCurrent
55111-399-0555111039905500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-399-05) 2010-10-150000-00-00NoNoCurrent
55111-399-305511103993030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-399-30) 2010-10-150000-00-00NoNoCurrent
55111-399-605511103996060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-399-60) 2010-10-150000-00-00NoNoCurrent
55111-399-79551110399791 BLISTER PACK in 1 CARTON (55111-399-79) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2010-10-150000-00-00NoNoCurrent
55111-399-905511103999090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-399-90) 2010-10-150000-00-00NoNoCurrent