AeroTab Ibuprofen

Product NDC
55305-133
11-digit product format
553050133
Labeler code
55305
Product ID
55305-133_2f179532-9c6f-6ed3-e063-6294a90ab2b7
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen tablet
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Aero Healthcare
Application
ANDA091239
Marketing category
ANDA
Marketing start
2018-01-01
Substance
IBUPROFEN
Active strength
200 mg/1000mg
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55305-133-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55305-133-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55305-133-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55305-133-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55305-133-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55305-133-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55305-133-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55305-133-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55305-133-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55305-133-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55305-133-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55305-133-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55305-133-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55305-133-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55305-133-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55305-133-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55305-133-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55305-133-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55305-133-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55305-133-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55305-133-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55305-133-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55305-133-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55305-133-04557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55305-133-058af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55305-133-038af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55305-133-028af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55305-133-048af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55305-133-05834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55305-133-03834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55305-133-02834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55305-133-04834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55305-133-051332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55305-133-031332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55305-133-021332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55305-133-041332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A091239-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2011-02-01

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013f01610625f2…
2019-09-15 20:21 UTC2019-09A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
AeroTab Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1000mg

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
310965Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ddd0f7fb-ae4b-c584-e053-2a95a90a0984Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55305-133-01AeroTab Ibuprofen2 mg in 1 PACKETTABLET, COATED22
55305-133-02AeroTab Ibuprofen25 in 1 BOXTABLET, COATED252
55305-133-03AeroTab Ibuprofen25 in 1 BOXTABLET, COATED252
55305-133-04AeroTab Ibuprofen50 in 1 BOXTABLET, COATED502
55305-133-05AeroTab Ibuprofen125 in 1 BOXTABLET, COATED1252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55305-133AEROTAB IBUPROFEN (IBUPROFEN TABLET) TABLET, COATED [AERO HEALTHCARE]2Current NDC, Legacy NDC, 5 package rows20250228_ddd0f7fb-ae4b-c584-e053-2a95a90a0984.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENGrocery Outlet, Inc.44660e1d-79c2-34ce-e063-6294a90ade3f2026-03-17WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENKroger Companybc173f1b-2e44-2c2e-e053-2a95a90a89c42025-09-24WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IbuprofenIBUPROFENTIME CAP LABORATORIES,INCf58d35f9-e44b-417b-98ce-0766b537cd2f2025-06-12WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENWALGREENS7653b33c-7489-10db-e053-2991aa0ab5082025-06-06WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
AeroTab IbuprofenIBUPROFEN TABLETAero Healthcareddd0f7fb-ae4b-c584-e053-2a95a90a09842025-02-26WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
ndc (product): 55305-133
VALUMEDS IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS LLCa6d4ceb0-2b79-496a-aa1e-27edd507ced02024-12-10WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IbuprofenIBUPROFENSAM'S WEST INC16595d75-6e74-0839-e063-6394a90abc132024-05-28WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENWALGREENS746f79aa-3036-1b9b-e053-2a91aa0a1db62024-03-18WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFEN CAIBUPROFENTARGET CORPORATION8e8684fa-095e-c6d6-e053-2a95a90a15b42024-01-03WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENTARGET CORPORATION8e86ae68-7687-79d6-e053-2995a90ac2742024-01-03WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IbuprofenIBUPROFENBETTER LIVING BRANDS, LLCeb613c44-e125-0f40-e053-2995a90a7ca52023-10-02WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IbuprofenIBUPROFENBETTER LIVING BRANDS, LLCeb60e636-41fe-49fb-e053-2a95a90a06162023-09-29WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
ibuprofenIBUPROFENDOLGENCORP INC8f1358aa-495a-23da-e053-2995a90aa4302023-01-02WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENRITE AID CORPORATIONa7aa790a-6d6c-7929-e053-2995a90a1cf82022-01-04WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IbuprofenIBUPROFENMARKSANS PHARMA LIMITED3c8df1e5-61bc-4e70-b6b9-8973986ad5892021-12-21WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENRITE AID CORPORATIONa7abac4c-7695-cfe8-e053-2a95a90ac1cd2021-10-30WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNddd0f7fb-ae4b-c584-e053-2a95a90a09842
310965ibuprofen 200 MG Oral TabletSCDddd0f7fb-ae4b-c584-e053-2a95a90a09842
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYddd0f7fb-ae4b-c584-e053-2a95a90a09842

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55305-133-01553050133012 mg in 1 PACKET2 mgHistorical
55305-133-025530501330225 PACKET in 1 BOX (55305-133-02) / 2 mg in 1 PACKET (55305-133-01) 25 packet2018-01-010000-00-00NoNoCurrent
55305-133-035530501330325 PACKET in 1 BOX (55305-133-03) / 2 mg in 1 PACKET (55305-133-01) 25 packet2018-01-010000-00-00NoNoCurrent
55305-133-045530501330450 PACKET in 1 BOX (55305-133-04) / 2 mg in 1 PACKET (55305-133-01) 50 packet2018-01-010000-00-00NoNoCurrent
55305-133-0555305013305125 PACKET in 1 BOX (55305-133-05) / 2 mg in 1 PACKET (55305-133-01) 125 packet2018-01-010000-00-00NoNoCurrent