FDA.reportPublic FDA data

Foster and Thrive Acid Reducer

Product NDC
70677-1099
11-digit product format
706771099
Labeler code
70677
Product ID
70677-1099_5c410f5e-26ec-470a-93cb-9be23e33e788
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA207193
Marketing category
ANDA
Marketing start
2024-02-15
Substance
ESOMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Foster and Thrive Acid Reducer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN3PA6559FT
Rxcui606726

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1099-1Foster and Thrive Acid Reducer1 in 1 CARTONCAPSULE, DELAYED RELEASE13
70677-1099-1Foster and Thrive Acid Reducer14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
70677-1099-2Foster and Thrive Acid Reducer2 in 1 CARTONCAPSULE, DELAYED RELEASE23
70677-1099-2Foster and Thrive Acid Reducer14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
70677-1099-3Foster and Thrive Acid Reducer3 in 1 CARTONCAPSULE, DELAYED RELEASE33
70677-1099-3Foster and Thrive Acid Reducer14 in 1 BOTTLECAPSULE, DELAYED RELEASE143

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1099-1EA - Each70677-10991d499c44-c64d-4eb3-8473-60e0ea7bded612024-07-12
70677-1099-2EA - Each70677-10998049f4f0-f118-4de5-97fc-9c067a3944ae12024-07-12
70677-1099-3EA - Each70677-109988e73d0c-bd33-4646-93d5-2235db9f094b12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1099FOSTER AND THRIVE ACID REDUCER (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 6 package rows20240224_32933772-c0ef-46ad-84e5-d70218bcc866.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN32933772-c0ef-46ad-84e5-d70218bcc8663
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD32933772-c0ef-46ad-84e5-d70218bcc8663
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY32933772-c0ef-46ad-84e5-d70218bcc8663
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY32933772-c0ef-46ad-84e5-d70218bcc8663

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1099-1706771099011 BOTTLE in 1 CARTON (70677-1099-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2024-02-15NoNoHistorical
70677-1099-2706771099022 BOTTLE in 1 CARTON (70677-1099-2) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2024-02-15NoNoHistorical
70677-1099-3706771099033 BOTTLE in 1 CARTON (70677-1099-3) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2024-02-15NoNoHistorical