FDA.reportPublic FDA data

ibuprofen

Product NDC
51672-5321
11-digit product format
516725321
Labeler code
51672
Product ID
51672-5321_56a6436c-f365-aae1-e063-6394a90a614c
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA211666
Marketing category
ANDA
Marketing start
2024-08-15
Substance
IBUPROFEN
Active strength
100 mg/5mL
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
A211666-001IBUPROFENIBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-22

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 22:38:342026-08A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-2284e616aacf4f…
2026-08-18 06:07:402026-07A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-224b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-2287673890dc5c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211666-001IBUPROFEN100MG/5MLSUSPENSION / ORAL2021-02-22a50c72e98297…

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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN100 mg/5mL

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
197803Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9de61620-6750-4fb6-89a4-fe451ab8d99fAvailable 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
51672-5321-1ibuprofen240 mL in 1 BOTTLE, PLASTICSUSPENSION2402
51672-5321-1ibuprofen1 in 1 CARTONSUSPENSION12
51672-5321-8ibuprofen1 in 1 CARTONSUSPENSION12
51672-5321-8ibuprofen120 mL in 1 BOTTLE, PLASTICSUSPENSION1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-5321-8ML - Milliliter51672-53213223b3f8-fa6d-4b6a-bcc8-3189b267902912025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-5321IBUPROFEN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]2Current NDC, 4 package rows20250315_9de61620-6750-4fb6-89a4-fe451ab8d99f.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ibuprofenIBUPROFENSun Pharmaceutical Industries, Inc.9de61620-6750-4fb6-89a4-fe451ab8d99f2026-07-15WarningsExact identifier
application applno (ANDA): 211666
application number: ANDA211666
ndc (product): 51672-5321
ibuprofenIBUPROFENA-S Medication Solutions7d4ba8be-df59-4a21-8850-8a59bf72b6042025-09-11WarningsExact identifier
application applno (ANDA): 211666
application number: ANDA211666

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN7d4ba8be-df59-4a21-8850-8a59bf72b6042
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN9de61620-6750-4fb6-89a4-fe451ab8d99f2
197803ibuprofen 20 MG/ML Oral SuspensionSCD7d4ba8be-df59-4a21-8850-8a59bf72b6042
197803ibuprofen 20 MG/ML Oral SuspensionSCD9de61620-6750-4fb6-89a4-fe451ab8d99f2
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY7d4ba8be-df59-4a21-8850-8a59bf72b6042
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY9de61620-6750-4fb6-89a4-fe451ab8d99f2
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY7d4ba8be-df59-4a21-8850-8a59bf72b6042
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY9de61620-6750-4fb6-89a4-fe451ab8d99f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51672-5321-1516725321011 BOTTLE, PLASTIC in 1 CARTON (51672-5321-1) / 240 mL in 1 BOTTLE, PLASTIC2024-10-10NoNoCurrent
51672-5321-8516725321081 BOTTLE, PLASTIC in 1 CARTON (51672-5321-8) / 120 mL in 1 BOTTLE, PLASTIC2024-08-15NoNoCurrent