FDA.reportPublic FDA data

Prevacid

Product NDC
64764-541
11-digit product format
647640541
Labeler code
64764
Product ID
64764-541_ac2f4316-0a09-466f-bf6d-4772fb633ecb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA020406
Marketing category
NDA
Marketing start
1995-05-10
Marketing end
0000-00-00
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
2023-12-31
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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64764-541-30EA - Each64764-541d3441685-1f25-4fc5-8be7-2ac185a693e412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36APREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
methacrylic acid - ethyl acrylate copolymer (1:1) type AINACTIVE INGREDIENTNX76LV5T8JPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
PHENYLALANINEINACTIVE INGREDIENT47E5O17Y3RPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletPSN7140f8d9-e478-4f69-a4eb-3fd4c94145762
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN7140f8d9-e478-4f69-a4eb-3fd4c94145762
351260lansoprazole 30 MG Delayed Release Disintegrating Oral TabletPSN7140f8d9-e478-4f69-a4eb-3fd4c94145762
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN7140f8d9-e478-4f69-a4eb-3fd4c94145762
596918Prevacid 15 MG Delayed Release Oral CapsulePSN7140f8d9-e478-4f69-a4eb-3fd4c94145762
206206Prevacid 30 MG Delayed Release Oral CapsulePSN7140f8d9-e478-4f69-a4eb-3fd4c94145762
206205Prevacid SoluTab 15 MG Delayed Release Disintegrating Oral TabletPSN7140f8d9-e478-4f69-a4eb-3fd4c94145762
866152Prevacid SoluTab 30 MG Delayed Release Disintegrating Oral TabletPSN7140f8d9-e478-4f69-a4eb-3fd4c94145762
596918lansoprazole 15 MG Delayed Release Oral Capsule [Prevacid]SBD7140f8d9-e478-4f69-a4eb-3fd4c94145762
206205lansoprazole 15 MG Disintegrating Oral Tablet [Prevacid]SBD7140f8d9-e478-4f69-a4eb-3fd4c94145762
206206lansoprazole 30 MG Delayed Release Oral Capsule [Prevacid]SBD7140f8d9-e478-4f69-a4eb-3fd4c94145762
866152lansoprazole 30 MG Disintegrating Oral Tablet [Prevacid]SBD7140f8d9-e478-4f69-a4eb-3fd4c94145762
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD7140f8d9-e478-4f69-a4eb-3fd4c94145762
351261lansoprazole 15 MG Disintegrating Oral TabletSCD7140f8d9-e478-4f69-a4eb-3fd4c94145762
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD7140f8d9-e478-4f69-a4eb-3fd4c94145762
351260lansoprazole 30 MG Disintegrating Oral TabletSCD7140f8d9-e478-4f69-a4eb-3fd4c94145762
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletSY7140f8d9-e478-4f69-a4eb-3fd4c94145762
351260lansoprazole 30 MG Delayed Release Disintegrating Oral TabletSY7140f8d9-e478-4f69-a4eb-3fd4c94145762
206205Prevacid 15 MG Delayed Release Disintegrating Oral TabletSY7140f8d9-e478-4f69-a4eb-3fd4c94145762
596918Prevacid 15 MG Delayed Release Oral CapsuleSY7140f8d9-e478-4f69-a4eb-3fd4c94145762
866152Prevacid 30 MG Delayed Release Disintegrating Oral TabletSY7140f8d9-e478-4f69-a4eb-3fd4c94145762
206206Prevacid 30 MG Delayed Release Oral CapsuleSY7140f8d9-e478-4f69-a4eb-3fd4c94145762
206205Prevacid SoluTab 15 MG Delayed Release Disintegrating Oral TabletSY7140f8d9-e478-4f69-a4eb-3fd4c94145762
866152Prevacid SoluTab 30 MG Delayed Release Disintegrating Oral TabletSY7140f8d9-e478-4f69-a4eb-3fd4c94145762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64764-541-05647640541055 BLISTER PACK in 1 TRAY (64764-541-05) > 4 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK5 blister pack1995-05-100000-00-00NoNoCurrent
64764-541-116476405411110 BLISTER PACK in 1 CARTON (64764-541-11) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK10 blister pack1995-05-100000-00-00NoNoCurrent
64764-541-19647640541191000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-541-19) 1995-05-100000-00-00NoNoCurrent
64764-541-306476405413030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-541-30) 1995-05-100000-00-00NoNoCurrent