FDA.reportPublic FDA data

Lansoprazole

Product NDC
55111-398
11-digit product format
551110398
Labeler code
55111
Product ID
55111-398_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
15 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
LANSOPRAZOLE15 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
55111-398-01Lansoprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10028
55111-398-05Lansoprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE50028
55111-398-30Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3028
55111-398-60Lansoprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE6028
55111-398-79Lansoprazole1 in 1 CARTONCAPSULE, DELAYED RELEASE128
55111-398-79Lansoprazole10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1028
55111-398-90Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-398-30EA - Each55111-3986bad8a1b-5e4c-408f-b16e-593e918a683a12012-07-24
55111-398-90EA - Each55111-39873191f0c-4070-4163-861c-6f205b57e49012012-07-24

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 [DIRECT RX]1
lansoprazoleACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
lansoprazoleACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
ammoniaINACTIVE INGREDIENT5138Q19F1XLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
ammoniaINACTIVE INGREDIENT5138Q19F1XLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
gelatinINACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
gelatinINACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
hydroxypropyl cellulose, low substitutedINACTIVE INGREDIENT2165RE0K14LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
magnesium carbonateINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
magnesium carbonateINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
methacrylic acid - ethyl acrylate copolymer (1:1) Type AINACTIVE INGREDIENTNX76LV5T8JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
methacrylic acid - ethyl acrylate copolymer (1:1) Type AINACTIVE INGREDIENTNX76LV5T8JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
raw sugarINACTIVE INGREDIENT8M707QY5GHLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
raw sugarINACTIVE INGREDIENT8M707QY5GHLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
shellacINACTIVE INGREDIENT46N107B71OLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
shellacINACTIVE INGREDIENT46N107B71OLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
starch, cornINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
starch, cornINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
sucroseINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
sucroseINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
talcINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1
talcINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-398LANSOPRAZOLE 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
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNe7a3aa37-9c9b-43fe-92be-6e0fdc8d1c92100
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDe7a3aa37-9c9b-43fe-92be-6e0fdc8d1c92100
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
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNe07c7445-9652-4833-8b17-45c0124c4e5d18
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDe07c7445-9652-4833-8b17-45c0124c4e5d18
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN960d6601-aec5-4900-a400-385b6687a4bc9
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD960d6601-aec5-4900-a400-385b6687a4bc9
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNc77da981-9260-fabd-e053-2a95a90aa71c6
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDc77da981-9260-fabd-e053-2a95a90aa71c6
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNe55d3f85-a6f2-42ff-a83d-645743c7cc6b5
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDe55d3f85-a6f2-42ff-a83d-645743c7cc6b5
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN6d81faf7-aa59-429c-e053-2a91aa0a8bb24
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD6d81faf7-aa59-429c-e053-2a91aa0a8bb24
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN7dcbbe7b-4eda-440a-e053-2a91aa0a41c12
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD7dcbbe7b-4eda-440a-e053-2a91aa0a41c12
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN22f416bf-00f1-ceb9-e063-6394a90aa1dd1
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN152fb727-d516-441e-a72b-33ddf1a325c11
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD152fb727-d516-441e-a72b-33ddf1a325c11
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD22f416bf-00f1-ceb9-e063-6394a90aa1dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-398-0155111039801100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-398-01) 2010-10-150000-00-00NoNoCurrent
55111-398-0555111039805500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-398-05) 2010-10-150000-00-00NoNoCurrent
55111-398-305511103983030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-398-30) 2010-10-150000-00-00NoNoCurrent
55111-398-605511103986060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-398-60) 2010-10-150000-00-00NoNoCurrent
55111-398-79551110398791 BLISTER PACK in 1 CARTON (55111-398-79) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2010-10-150000-00-00NoNoCurrent
55111-398-905511103989090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-398-90) 2010-10-150000-00-00NoNoCurrent