FDA.reportPublic FDA data

Foster and Thrive Ibuprofen

Product NDC
70677-1146
11-digit product format
706771146
Labeler code
70677
Product ID
70677-1146_f92e1443-6640-422a-9b27-32e515a1335d
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA075217
Marketing category
ANDA
Marketing start
2024-02-07
Substance
IBUPROFEN
Active strength
50 mg/1.25mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
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 Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN50 mg/1.25mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui204442

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1146-1Foster and Thrive Ibuprofen30 mL in 1 BOTTLESUSPENSION/ DROPS303
70677-1146-1Foster and Thrive Ibuprofen1 in 1 CARTONSUSPENSION/ DROPS13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1146-1ML - Milliliter70677-11460a6eeb1d-a5de-4121-8ea3-bf452044b9a812024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1146FOSTER AND THRIVE IBUPROFEN (IBUPROFEN) SUSPENSION/ DROPS [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 2 package rows20250416_bcfa45ac-63d6-49a7-aa1c-b9f1d6c571f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204442ibuprofen 50 MG in 1.25 mL Oral SuspensionPSNbcfa45ac-63d6-49a7-aa1c-b9f1d6c571f33
204442ibuprofen 40 MG/ML Oral SuspensionSCDbcfa45ac-63d6-49a7-aa1c-b9f1d6c571f33
204442ibuprofen 50 MG per 1.25 ML Oral SuspensionSYbcfa45ac-63d6-49a7-aa1c-b9f1d6c571f33
204442ibuprofen 50 MG per 1.25 ML Oral Suspension DropsSYbcfa45ac-63d6-49a7-aa1c-b9f1d6c571f33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1146-1706771146011 BOTTLE in 1 CARTON (70677-1146-1) / 30 mL in 1 BOTTLE1 bottle2024-02-07NoNoHistorical