FDA.reportPublic FDA data

Ibuprofen

Product NDC
51013-103
11-digit product format
510130103
Labeler code
51013
Product ID
51013-103_b23cc43f-3c8b-496a-b6d4-eb260344372d
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
PuraCap Pharmaceutical LLC
Application
ANDA206568
Marketing category
ANDA
Marketing start
2016-10-12
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
51013-103-15Ibuprofen20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED206
51013-103-15Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED16
51013-103-22Ibuprofen60 in 1 BOTTLECAPSULE, LIQUID FILLED606
51013-103-25Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED16
51013-103-25Ibuprofen40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED406
51013-103-26Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED16
51013-103-26Ibuprofen80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED806
51013-103-28Ibuprofen160 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1606
51013-103-28Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED16
51013-103-29Ibuprofen180 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1806
51013-103-31Ibuprofen300 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED3006
51013-103-38Ibuprofen200 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2006
51013-103-39Ibuprofen120 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1206
51013-103-41Ibuprofen400 in 1 BOTTLECAPSULE, LIQUID FILLED4006
51013-103-42Ibuprofen800 in 1 BOTTLECAPSULE, LIQUID FILLED8006
51013-103-63Ibuprofen10 in 1 BOTTLECAPSULE, LIQUID FILLED106
51013-103-63Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-103IBUPROFEN CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]6Current NDC, Legacy NDC, 17 package rows20191211_67e09ad5-e010-4aa1-b86e-9b22331bf33b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN67e09ad5-e010-4aa1-b86e-9b22331bf33b6
310964ibuprofen 200 MG Oral CapsuleSCD67e09ad5-e010-4aa1-b86e-9b22331bf33b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51013-103-15510130103151 BOTTLE, PLASTIC in 1 CARTON (51013-103-15) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2016-10-120000-00-00NoNoCurrent
51013-103-225101301032260 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-103-22) 2017-05-160000-00-00NoNoCurrent
51013-103-25510130103251 BOTTLE, PLASTIC in 1 CARTON (51013-103-25) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2016-10-120000-00-00NoNoCurrent
51013-103-26510130103261 BOTTLE, PLASTIC in 1 CARTON (51013-103-26) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2016-10-120000-00-00NoNoCurrent
51013-103-28510130103281 BOTTLE, PLASTIC in 1 CARTON (51013-103-28) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2016-10-120000-00-00NoNoCurrent
51013-103-2951013010329180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (51013-103-29) 2016-10-120000-00-00NoNoCurrent
51013-103-3151013010331300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (51013-103-31) 2016-10-120000-00-00NoNoCurrent
51013-103-3851013010338200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (51013-103-38) 2016-10-120000-00-00NoNoCurrent
51013-103-3951013010339120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (51013-103-39) 2016-10-120000-00-00NoNoCurrent
51013-103-4151013010341400 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-103-41) 2017-05-160000-00-00NoNoCurrent
51013-103-4251013010342800 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-103-42) 2017-05-160000-00-00NoNoCurrent
51013-103-63510130103631 BOTTLE in 1 CARTON (51013-103-63) / 10 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2017-08-170000-00-00NoNoCurrent