FDA.reportPublic FDA data

Lansoprazole

Product NDC
64679-140
11-digit product format
646790140
Labeler code
64679
Product ID
64679-140_4998725b-6599-42ce-8fb3-af29ebef766c
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
ANDA202727
Marketing category
ANDA
Marketing start
2012-05-18
Marketing end
0000-00-00
Substance
LANSOPRAZOLE
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64679-140-002024-11-15C16284748780-1e4f33bdf-a8e1-d8a0-e053-dadaa90a6e4e5d3a0259-83ac-4a3b-94f0-881132bd1978
64679-140-012024-11-15C16284748780-1e4f33bdf-a8e1-d8a0-e053-dadaa90a6e4e5d3a0259-83ac-4a3b-94f0-881132bd1978
64679-140-072024-11-15C16284748780-1e4f33bdf-a8e1-d8a0-e053-dadaa90a6e4e5d3a0259-83ac-4a3b-94f0-881132bd1978
64679-140-082024-11-15C16284748780-1e4f33bdf-a8e1-d8a0-e053-dadaa90a6e4e5d3a0259-83ac-4a3b-94f0-881132bd1978
64679-140-092024-11-15C16284748780-1e4f33bdf-a8e1-d8a0-e053-dadaa90a6e4e5d3a0259-83ac-4a3b-94f0-881132bd1978
64679-140-102024-11-15C16284748780-1e4f33bdf-a8e1-d8a0-e053-dadaa90a6e4e5d3a0259-83ac-4a3b-94f0-881132bd1978
64679-140-112024-11-15C16284748780-1e4f33bdf-a8e1-d8a0-e053-dadaa90a6e4e5d3a0259-83ac-4a3b-94f0-881132bd1978
64679-140-002022-07-29C16284748780-1e4f33bdf-a8e1-d8a0-e053-dadaa90a6e4e5d3a0259-83ac-4a3b-94f0-881132bd1978
64679-140-012022-07-29C16284748780-1e4f33bdf-a8e1-d8a0-e053-dadaa90a6e4e5d3a0259-83ac-4a3b-94f0-881132bd1978
64679-140-072022-07-29C16284748780-1e4f33bdf-a8e1-d8a0-e053-dadaa90a6e4e5d3a0259-83ac-4a3b-94f0-881132bd1978
64679-140-082022-07-29C16284748780-1e4f33bdf-a8e1-d8a0-e053-dadaa90a6e4e5d3a0259-83ac-4a3b-94f0-881132bd1978
64679-140-092022-07-29C16284748780-1e4f33bdf-a8e1-d8a0-e053-dadaa90a6e4e5d3a0259-83ac-4a3b-94f0-881132bd1978
64679-140-102022-07-29C16284748780-1e4f33bdf-a8e1-d8a0-e053-dadaa90a6e4e5d3a0259-83ac-4a3b-94f0-881132bd1978
64679-140-112022-07-29C16284748780-1e4f33bdf-a8e1-d8a0-e053-dadaa90a6e4e5d3a0259-83ac-4a3b-94f0-881132bd1978

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13LANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN5cd41b0a-190d-4460-a536-aa401dc0abb42
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD5cd41b0a-190d-4460-a536-aa401dc0abb42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64679-140-00646790140004500 CAPSULE, DELAYED RELEASE in 1 POUCH (64679-140-00) 2012-05-180000-00-00NoNoCurrent
64679-140-01646790140011 BOTTLE in 1 CARTON (64679-140-01) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2012-05-180000-00-00NoNoCurrent
64679-140-07646790140071 BLISTER PACK in 1 CARTON (64679-140-07) > 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2012-05-180000-00-00NoNoCurrent
64679-140-08646790140082 BOTTLE in 1 CARTON (64679-140-08) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2012-05-180000-00-00NoNoCurrent
64679-140-09646790140093 BOTTLE in 1 CARTON (64679-140-09) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2012-05-180000-00-00NoNoCurrent
64679-140-10646790140102 BLISTER PACK in 1 CARTON (64679-140-10) > 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2012-05-180000-00-00NoNoCurrent
64679-140-11646790140113 BLISTER PACK in 1 CARTON (64679-140-11) > 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK3 blister pack2012-05-180000-00-00NoNoCurrent