FDA.reportPublic FDA data

foster and thrive acid reducer

Product NDC
70677-1103
11-digit product format
706771103
Labeler code
70677
Product ID
70677-1103_0cef3ac4-fc0c-4d1e-a7e3-922b514edd40
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA202319
Marketing category
ANDA
Marketing start
2023-09-14
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
foster and thrive 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
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1103-1foster and thrive acid reducer14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
70677-1103-1foster and thrive acid reducer1 in 1 CARTONCAPSULE, DELAYED RELEASE12
70677-1103-2foster and thrive acid reducer3 in 1 CARTONCAPSULE, DELAYED RELEASE32
70677-1103-2foster and thrive acid reducer14 in 1 BOTTLECAPSULE, DELAYED RELEASE142

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1103-1EA - Each70677-110363b9b315-fbff-45ae-8d9b-257a67ed349b12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1103FOSTER AND THRIVE ACID REDUCER (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 4 package rows20230915_d02e2f93-3358-4682-b491-0a83889af8a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNd02e2f93-3358-4682-b491-0a83889af8a12
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDd02e2f93-3358-4682-b491-0a83889af8a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1103-1706771103011 BOTTLE in 1 CARTON (70677-1103-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2023-09-14NoNoHistorical
70677-1103-2706771103023 BOTTLE in 1 CARTON (70677-1103-2) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2023-09-14NoNoHistorical