Flex-Prin

Product NDC
69103-2525
11-digit product format
691032525
Labeler code
69103
Product ID
69103-2525_f18ebbe5-cd44-8c27-e053-2a95a90ab79b
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Provision Medical Products
Application
ANDA079129
Marketing category
ANDA
Marketing start
2015-03-31
Substance
IBUPROFEN
Active strength
200 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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A079129-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2011-03-28

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283f01610625f2…
2019-09-15 20:21 UTC2019-09A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Flex-Prin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

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
c01538b0-ca4c-434a-be8f-fe023deb84e1Available 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
69103-2525-5Flex-Prin2 in 1 PACKETTABLET23
69103-2525-5Flex-Prin250 in 1 CARTONTABLET2503
69103-2525-6Flex-Prin2 in 1 PACKETTABLET23
69103-2525-6Flex-Prin100 in 1 CARTONTABLET1003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMFLEX-PRIN (IBUPROFEN) TABLET [PROVISION MEDICAL PRODUCTS]1
IBUPROFENACTIVE MOIETYWK2XYI10QMFLEX-PRIN (IBUPROFEN) TABLET [PROVISION MEDICAL PRODUCTS]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZFLEX-PRIN (IBUPROFEN) TABLET [PROVISION MEDICAL PRODUCTS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLEX-PRIN (IBUPROFEN) TABLET [PROVISION MEDICAL PRODUCTS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FLEX-PRIN (IBUPROFEN) TABLET [PROVISION MEDICAL PRODUCTS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFLEX-PRIN (IBUPROFEN) TABLET [PROVISION MEDICAL PRODUCTS]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFLEX-PRIN (IBUPROFEN) TABLET [PROVISION MEDICAL PRODUCTS]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLEX-PRIN (IBUPROFEN) TABLET [PROVISION MEDICAL PRODUCTS]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XFLEX-PRIN (IBUPROFEN) TABLET [PROVISION MEDICAL PRODUCTS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLEX-PRIN (IBUPROFEN) TABLET [PROVISION MEDICAL PRODUCTS]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJFLEX-PRIN (IBUPROFEN) TABLET [PROVISION MEDICAL PRODUCTS]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFLEX-PRIN (IBUPROFEN) TABLET [PROVISION MEDICAL PRODUCTS]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFLEX-PRIN (IBUPROFEN) TABLET [PROVISION MEDICAL PRODUCTS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLEX-PRIN (IBUPROFEN) TABLET [PROVISION MEDICAL PRODUCTS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69103-2525FLEX-PRIN (IBUPROFEN) TABLET [PROVISION MEDICAL PRODUCTS]3Current NDC, Legacy NDC, 4 package rows20230107_c01538b0-ca4c-434a-be8f-fe023deb84e1.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENPioneer Life Sciences, LLC8abd74a4-ad33-4c10-b677-acb469f815e62026-08-03WarningsExact identifier
application applno (ANDA): 079129
application number: ANDA079129
IbuprofenIBUPROFENNUVICARE LLC7905edc1-2a45-4adc-a7bc-42b1ddb6ba592026-08-03WarningsExact identifier
application applno (ANDA): 079129
application number: ANDA079129
IbuprofenIBUPROFENFamily Dollar (FAMILY WELLNESS)5beb7c11-4ed4-4cd4-9c30-3b0c4016316f2026-05-27WarningsExact identifier
application applno (ANDA): 079129
application number: ANDA079129
IbuprofenIBUPROFENFamily Dollar (FAMILY WELLNESS)da16b1a9-0db2-4f2f-bc85-05ea5ab26e1c2026-05-27WarningsExact identifier
application applno (ANDA): 079129
application number: ANDA079129
IBUPROFEN Immediate ReleaseIBUPROFENStrides Pharma Inca5dd275f-f388-44ec-8297-74430a742d522026-03-24Boxed warning, WarningsExact identifier
application applno (ANDA): 079129
application number: ANDA079129
CVS IbuprofenIBUPROFENCVS Pharmacy3d71e29f-0648-7377-e063-6294a90a8a292026-02-17WarningsExact identifier
application applno (ANDA): 079129
application number: ANDA079129
IbuprofenIBUPROFENStrategic Sourcing Services, LLCdc469eb2-89cc-46c9-9304-f6cf119c05702026-01-29WarningsExact identifier
application applno (ANDA): 079129
application number: ANDA079129
IbuprofenIBUPROFENAAA Pharmaceutical, Inc.fbc7fb61-d295-464b-9f3b-52262ed6f31a2025-12-09WarningsExact identifier
application applno (ANDA): 079129
application number: ANDA079129
RIGHT REMEDIES Ibuprofen 200 MGIBUPROFENStrive Pharmaceuticals Inc.5c155210-d16f-487e-983d-c7b0f97365c62025-10-08WarningsExact identifier
application applno (ANDA): 079129
application number: ANDA079129
IbuprofenIBUPROFENAAA Pharmaceutical, Inc.39e55ec1-213f-4996-adca-68a5ffbc409b2024-12-06WarningsExact identifier
application applno (ANDA): 079129
application number: ANDA079129
IbuprofenIBUPROFENP & L Development, LLC6d1c9a64-c83c-4b3d-9245-704b94cb367c2024-07-30WarningsExact identifier
application applno (ANDA): 079129
application number: ANDA079129
Ibuprofen, Circle K, 50ctIBUPROFENLil' Drug Store Products, Inc.1ab6fbae-ead5-283b-e063-6394a90a4ed42024-06-12WarningsExact identifier
application applno (ANDA): 079129
application number: ANDA079129
IbuprofenIBUPROFENFamily Dollar (FAMILY WELLNESS)eaa0a286-a0f0-4979-8af3-c5f4194283fd2023-06-22WarningsExact identifier
application applno (ANDA): 079129
application number: ANDA079129
Flex-PrinIBUPROFENProvision Medical Productsc01538b0-ca4c-434a-be8f-fe023deb84e12023-01-05WarningsExact identifier
application applno (ANDA): 079129
application number: ANDA079129
ndc (product): 69103-2525
Ibuprofen Fast relief medicine for painIBUPROFEN 200 MGAllegiant Healthdd63b011-0573-4374-9669-8d29146e5fc92017-11-17WarningsExact identifier
application applno (ANDA): 079129
application number: ANDA079129

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNc01538b0-ca4c-434a-be8f-fe023deb84e13
310965ibuprofen 200 MG Oral TabletSCDc01538b0-ca4c-434a-be8f-fe023deb84e13
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYc01538b0-ca4c-434a-be8f-fe023deb84e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69103-2525-569103252505250 PACKET in 1 CARTON (69103-2525-5) / 2 TABLET in 1 PACKET250 packet2015-04-050000-00-00NoNoCurrent
69103-2525-669103252506100 PACKET in 1 CARTON (69103-2525-6) / 2 TABLET in 1 PACKET100 packet2015-04-050000-00-00NoNoCurrent