FDA.reportPublic FDA data

Ibuprofen

Product NDC
11788-008
11-digit product format
117880008
Labeler code
11788
Product ID
11788-008_e2acadb4-d270-49d4-92cd-33db4f635fdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AiPing Pharmaceutical, Inc.
Application
ANDA202413
Marketing category
ANDA
Marketing start
2025-12-15
Substance
IBUPROFEN
Active strength
400 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
IBUPROFEN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805, 197806, 197807

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
11788-008-012026-01-20C16284748780-11030e365-4541-111a-e063-dadaa90a10e2Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg
11788-008-052026-01-20C16284748780-11030e365-4541-111a-e063-dadaa90a10e2Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg
11788-008-002024-01-30C16284748780-11030e365-6608-111a-e063-dadaa90a10e2Ibuprofen Tablets, USP 400 mg, 600 mg and 800 mg
11788-008-012024-01-30C16284748780-11030e365-4541-111a-e063-dadaa90a10e2Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg
11788-008-052024-01-30C16284748780-11030e365-4541-111a-e063-dadaa90a10e2Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11788-008-01Ibuprofen100 in 1 BOTTLETABLET, FILM COATED10020
11788-008-05Ibuprofen500 in 1 BOTTLETABLET, FILM COATED50020
11788-008-00ibuprofen34000 in 1 CARTONTABLET, FILM COATED340008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11788-008-01EA - Each11788-0083291da2f-64d3-44d9-bff0-a8024a287caa12019-09-05
11788-008-05EA - Each11788-008833b8353-d062-4d26-b57a-bee052083aec12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11788-008IBUPROFEN TABLET, FILM COATED [AIPING PHARMACEUTICAL INC.]17Current NDC, Legacy NDC, 2 package rows20220116_3e131710-2579-446e-8076-f602ecea813f.zip
11788-008IBUPROFEN TABLET, FILM COATED [AIPING PHARMACEUTICAL, INC.]8Current NDC, Legacy NDC, 1 package rows20200514_3e4713d6-17cc-4296-9eb2-2edb837456a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN3e131710-2579-446e-8076-f602ecea813f20
197806ibuprofen 600 MG Oral TabletPSN3e131710-2579-446e-8076-f602ecea813f20
197807ibuprofen 800 MG Oral TabletPSN3e131710-2579-446e-8076-f602ecea813f20
197805ibuprofen 400 MG Oral TabletSCD3e131710-2579-446e-8076-f602ecea813f20
197806ibuprofen 600 MG Oral TabletSCD3e131710-2579-446e-8076-f602ecea813f20
197807ibuprofen 800 MG Oral TabletSCD3e131710-2579-446e-8076-f602ecea813f20
197805ibuprofen 400 MG Oral TabletPSN3e4713d6-17cc-4296-9eb2-2edb837456a98
197806ibuprofen 600 MG Oral TabletPSN3e4713d6-17cc-4296-9eb2-2edb837456a98
197807ibuprofen 800 MG Oral TabletPSN3e4713d6-17cc-4296-9eb2-2edb837456a98
197805ibuprofen 400 MG Oral TabletSCD3e4713d6-17cc-4296-9eb2-2edb837456a98
197806ibuprofen 600 MG Oral TabletSCD3e4713d6-17cc-4296-9eb2-2edb837456a98
197807ibuprofen 800 MG Oral TabletSCD3e4713d6-17cc-4296-9eb2-2edb837456a98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11788-008-001178800080034000 TABLET, FILM COATED in 1 CARTON (11788-008-00) 2018-11-010000-00-00NoNoCurrent
11788-008-0111788000801100 TABLET, FILM COATED in 1 BOTTLE (11788-008-01) 2025-12-150000-00-00NoNoCurrent
11788-008-0511788000805500 TABLET, FILM COATED in 1 BOTTLE (11788-008-05) 2025-12-150000-00-00NoNoCurrent