signature care acid reducer

Product NDC
21130-181
11-digit product format
211300181
Labeler code
21130
Product ID
21130-181_67c3369b-43a7-4a90-871d-d5ea4219f1d6
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Safeway
Application
ANDA202319
Marketing category
ANDA
Marketing start
2015-09-27
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
signature care acid reducer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K5C5T2QPG
Rxcui596843

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-181-01signature care acid reducer1 in 1 CARTONCAPSULE, DELAYED RELEASE15
21130-181-01signature care acid reducer14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
21130-181-03signature care acid reducer42 in 1 BOTTLECAPSULE, DELAYED RELEASE425
21130-181-03signature care acid reducer1 in 1 CARTONCAPSULE, DELAYED RELEASE15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGSIGNATURE CARE ACID REDUCER (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [SAFEWAY]1
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGSIGNATURE CARE ACID REDUCER (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [SAFEWAY]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHSIGNATURE CARE ACID REDUCER (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [SAFEWAY]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSIGNATURE CARE ACID REDUCER (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [SAFEWAY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSIGNATURE CARE ACID REDUCER (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [SAFEWAY]1
GELATININACTIVE INGREDIENT2G86QN327LSIGNATURE CARE ACID REDUCER (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [SAFEWAY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIGNATURE CARE ACID REDUCER (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [SAFEWAY]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ASIGNATURE CARE ACID REDUCER (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [SAFEWAY]1
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYSIGNATURE CARE ACID REDUCER (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [SAFEWAY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASIGNATURE CARE ACID REDUCER (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [SAFEWAY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSIGNATURE CARE ACID REDUCER (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [SAFEWAY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSIGNATURE CARE ACID REDUCER (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [SAFEWAY]1
TALCINACTIVE INGREDIENT7SEV7J4R1USIGNATURE CARE ACID REDUCER (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [SAFEWAY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIGNATURE CARE ACID REDUCER (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [SAFEWAY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-181SIGNATURE CARE ACID REDUCER (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [SAFEWAY]5Current NDC, Legacy NDC, 4 package rows20200327_179699b4-7d72-4ebe-912d-3f00e58d9324.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN179699b4-7d72-4ebe-912d-3f00e58d93245
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD179699b4-7d72-4ebe-912d-3f00e58d93245

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-181-01211300181011 BOTTLE in 1 CARTON (21130-181-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2015-09-270000-00-00NoNoCurrent
21130-181-03211300181031 BOTTLE in 1 CARTON (21130-181-03) / 42 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2015-09-270000-00-00NoNoCurrent