FDA.reportPublic FDA data

Ibuprofen

Product NDC
36800-221
11-digit product format
368000221
Labeler code
36800
Product ID
36800-221_427c1aff-4849-1146-e063-6394a90ac0e9
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
ANDA078682
Marketing category
ANDA
Marketing start
2021-08-18
Substance
IBUPROFEN
Active strength
200 mg/1
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
Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310964

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
36800-221-11Ibuprofen20 in 1 BOTTLECAPSULE, LIQUID FILLED205
36800-221-11Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED15
36800-221-78Ibuprofen80 in 1 BOTTLECAPSULE, LIQUID FILLED805
36800-221-78Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED15
36800-221-79Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED15
36800-221-79Ibuprofen160 in 1 BOTTLECAPSULE, LIQUID FILLED1605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-221IBUPROFEN CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]4Current NDC, Legacy NDC, 6 package rows20231011_c62cc12f-5a0e-389a-e053-2995a90a208c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSNc62cc12f-5a0e-389a-e053-2995a90a208c5
310964ibuprofen 200 MG Oral CapsuleSCDc62cc12f-5a0e-389a-e053-2995a90a208c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-221-11368000221111 BOTTLE in 1 CARTON (36800-221-11) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2021-08-180000-00-00NoNoCurrent
36800-221-78368000221781 BOTTLE in 1 CARTON (36800-221-78) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2021-08-180000-00-00NoNoCurrent
36800-221-79368000221791 BOTTLE in 1 CARTON (36800-221-79) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2023-10-10NoNoHistorical