FDA.reportPublic FDA data

IBUPROFEN

Product NDC
59556-764
11-digit product format
595560764
Labeler code
59556
Product ID
59556-764_7d889b12-7d30-423f-a988-bb1d201ebb59
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Strides Pharma Inc
Application
ANDA204469
Marketing category
ANDA
Marketing start
2022-11-16
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IBUPROFEN
Listing expiration
2027-12-31

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
59556-764-11IBUPROFEN120 in 1 BOTTLECAPSULE, LIQUID FILLED1209
59556-764-11IBUPROFEN1 in 1 CARTONCAPSULE, LIQUID FILLED19
59556-764-12IBUPROFEN1 in 1 CARTONCAPSULE, LIQUID FILLED19
59556-764-12IBUPROFEN40 in 1 BOTTLECAPSULE, LIQUID FILLED409
59556-764-13IBUPROFEN1 in 1 CARTONCAPSULE, LIQUID FILLED19
59556-764-13IBUPROFEN80 in 1 BOTTLECAPSULE, LIQUID FILLED809
59556-764-18IBUPROFEN1 in 1 CARTONCAPSULE, LIQUID FILLED19
59556-764-18IBUPROFEN180 in 1 BOTTLECAPSULE, LIQUID FILLED1809
59556-764-29IBUPROFEN1 in 1 CARTONCAPSULE, LIQUID FILLED19
59556-764-29IBUPROFEN20 in 1 BOTTLECAPSULE, LIQUID FILLED209
59556-764-48IBUPROFEN1 in 1 CARTONCAPSULE, LIQUID FILLED19
59556-764-48IBUPROFEN160 in 1 BOTTLECAPSULE, LIQUID FILLED1609
59556-764-49IBUPROFEN1 in 1 CARTONCAPSULE, LIQUID FILLED19
59556-764-49IBUPROFEN200 in 1 BOTTLECAPSULE, LIQUID FILLED2009
59556-764-50IBUPROFEN300 in 1 BOTTLECAPSULE, LIQUID FILLED3009
59556-764-50IBUPROFEN1 in 1 CARTONCAPSULE, LIQUID FILLED19
59556-764-92IBUPROFEN3000 in 1 BAGCAPSULE, LIQUID FILLED30009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59556-764IBUPROFEN CAPSULE, LIQUID FILLED [STRIDES PHARMA INC]8Current NDC, Legacy NDC, 17 package rows20240417_69b208ff-83f5-40d1-a2ff-d54b390e46e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN69b208ff-83f5-40d1-a2ff-d54b390e46e49
310964ibuprofen 200 MG Oral CapsuleSCD69b208ff-83f5-40d1-a2ff-d54b390e46e49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59556-764-11595560764111 BOTTLE in 1 CARTON (59556-764-11) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2022-11-160000-00-00NoNoCurrent
59556-764-12595560764121 BOTTLE in 1 CARTON (59556-764-12) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2022-11-160000-00-00NoNoCurrent
59556-764-13595560764131 BOTTLE in 1 CARTON (59556-764-13) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2022-11-160000-00-00NoNoCurrent
59556-764-18595560764181 BOTTLE in 1 CARTON (59556-764-18) / 180 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2022-11-16NoNoHistorical
59556-764-29595560764291 BOTTLE in 1 CARTON (59556-764-29) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2022-11-160000-00-00NoNoCurrent
59556-764-48595560764481 BOTTLE in 1 CARTON (59556-764-48) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2022-11-160000-00-00NoNoCurrent
59556-764-49595560764491 BOTTLE in 1 CARTON (59556-764-49) / 200 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2022-11-160000-00-00NoNoCurrent
59556-764-50595560764501 BOTTLE in 1 CARTON (59556-764-50) / 300 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2022-11-160000-00-00NoNoCurrent
59556-764-92595560764923000 CAPSULE, LIQUID FILLED in 1 BAG (59556-764-92) 2022-11-16NoNoHistorical