FDA.reportPublic FDA data

Ibuprofen

Product NDC
70512-780
11-digit product format
705120780
Labeler code
70512
Product ID
70512-780_28500a4a-9c67-72a6-e063-6394a90a26d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
SOLA Pharmaceuticals, LLC
Application
ANDA078329
Marketing category
ANDA
Marketing start
2024-12-01
Substance
IBUPROFEN
Active strength
800 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
IBUPROFEN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197807

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
70512-780-10Ibuprofen100 in 1 BOTTLETABLET1002
70512-780-50Ibuprofen500 in 1 BOTTLETABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70512-780-10EA - Each70512-780b25aad1e-ab3b-4628-8023-d18b28c7717112025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70512-780IBUPROFEN TABLET [SOLA PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20241204_b19b8c34-e0c1-4982-92fc-34dbe7384935.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSNb19b8c34-e0c1-4982-92fc-34dbe73849352
197807ibuprofen 800 MG Oral TabletSCDb19b8c34-e0c1-4982-92fc-34dbe73849352
197807ibuprofen 800 MG Oral TabletPSN3b9fdc48-c071-4e2c-e063-6294a90a679f1
197807ibuprofen 800 MG Oral TabletPSNd7ed42c4-371c-4a54-ab15-0630656f04271
197807ibuprofen 800 MG Oral TabletSCD3b9fdc48-c071-4e2c-e063-6294a90a679f1
197807ibuprofen 800 MG Oral TabletSCDd7ed42c4-371c-4a54-ab15-0630656f04271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70512-780-1070512078010100 TABLET in 1 BOTTLE (70512-780-10) 100 tablet2024-12-01NoNoCurrent
70512-780-5070512078050500 TABLET in 1 BOTTLE (70512-780-50) 500 tablet2024-12-01NoNoCurrent