FDA.reportPublic FDA data

IBUPROFEN

Product NDC
51672-2146
Requested package NDC
51672-2146-3
11-digit product format
516722146
Labeler code
51672
Product ID
51672-2146_4db5c2e1-85e1-4689-e063-6294a90aaf91
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA217261
Marketing category
ANDA
Marketing start
2023-08-08
Substance
IBUPROFEN
Active strength
50 mg/1.25mL
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217261-001IBUPROFENIBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-0884e616aacf4f…
2026-08-18 06:07:402026-07A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-088072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-089b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217261-001IBUPROFEN40MG/MLSUSPENSION/DROPS / ORAL2023-08-08a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN50 mg/1.25mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204442Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bc816597-a85a-4143-9f99-bb0699ca57c5Available on FDA.report

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
51672-2146-3IBUPROFENInfants30 mL in 1 BOTTLESUSPENSION/ DROPS306
51672-2146-3IBUPROFENInfants1 in 1 CARTONSUSPENSION/ DROPS16
51672-2146-5IBUPROFENInfants1 in 1 CARTONSUSPENSION/ DROPS16
51672-2146-5IBUPROFENInfants15 mL in 1 BOTTLESUSPENSION/ DROPS156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2146IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [-SUN PHARMACEUTICAL INDUSTRIES, INC.]4Current NDC, 4 package rows20250406_bc816597-a85a-4143-9f99-bb0699ca57c5.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPROFEN InfantsIBUPROFENSun Pharmaceutical Industries, Inc.bc816597-a85a-4143-9f99-bb0699ca57c52026-03-23WarningsExact identifier
application applno (ANDA): 217261
application number: ANDA217261
ndc (package): 51672-2146-3
ndc (product): 51672-2146
ndc11 (package): 51672214603

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204442ibuprofen 50 MG in 1.25 mL Oral SuspensionPSNbc816597-a85a-4143-9f99-bb0699ca57c56
204442ibuprofen 40 MG/ML Oral SuspensionSCDbc816597-a85a-4143-9f99-bb0699ca57c56
204442ibuprofen 50 MG per 1.25 ML Oral SuspensionSYbc816597-a85a-4143-9f99-bb0699ca57c56
204442ibuprofen 50 MG per 1.25 ML Oral Suspension DropsSYbc816597-a85a-4143-9f99-bb0699ca57c56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51672-2146-3516722146031 BOTTLE in 1 CARTON (51672-2146-3) / 30 mL in 1 BOTTLE1 bottle2023-08-08NoNoCurrent