FDA.reportPublic FDA data

Ibuprofen

Product NDC
11822-0894
11-digit product format
118220894
Labeler code
11822
Product ID
11822-0894_2131107b-a8b1-4241-9bf2-e096b59cb19a
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA206999
Marketing category
ANDA
Marketing start
2020-01-31
Marketing end
2026-12-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-0894-12023-02-20C16284748780-1d6a99b39-d680-a426-e053-dadaa90af4c2Drug Facts
11822-0894-22023-02-20C16284748780-1d6a99b39-d680-a426-e053-dadaa90af4c2Drug Facts
11822-0894-82023-02-20C16284748780-1d6a99b39-d680-a426-e053-dadaa90af4c2Drug Facts
11822-0894-92023-02-20C16284748780-1d6a99b39-d680-a426-e053-dadaa90af4c2Drug Facts
11822-0894-12022-01-28C16284748780-1d6a99b39-d680-a426-e053-dadaa90af4c2Drug Facts
11822-0894-22022-01-28C16284748780-1d6a99b39-d680-a426-e053-dadaa90af4c2Drug Facts
11822-0894-82022-01-28C16284748780-1d6a99b39-d680-a426-e053-dadaa90af4c2Drug Facts
11822-0894-92022-01-28C16284748780-1d6a99b39-d680-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0894-1Ibuprofen160 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1603
11822-0894-2Ibuprofen80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED803
11822-0894-2Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED13
11822-0894-8Ibuprofen300 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED3003
11822-0894-9Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED13
11822-0894-9Ibuprofen40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0894IBUPROFEN CAPSULE, LIQUID FILLED [RITE AID CORPORATION]2Current NDC, Legacy NDC, 6 package rows20230221_47657d95-4a54-49c2-8273-86b413b8f41e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN47657d95-4a54-49c2-8273-86b413b8f41e3
310964ibuprofen 200 MG Oral CapsuleSCD47657d95-4a54-49c2-8273-86b413b8f41e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11822-0894-111822089401160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (11822-0894-1) 2020-01-312026-12-31NoNoCurrent
11822-0894-2118220894021 BOTTLE, PLASTIC in 1 CARTON (11822-0894-2) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2020-01-312026-12-31NoNoCurrent
11822-0894-811822089408300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (11822-0894-8) 2020-01-312026-12-31NoNoCurrent
11822-0894-9118220894091 BOTTLE, PLASTIC in 1 BOX (11822-0894-9) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2020-01-312026-12-31NoNoCurrent