Ibuprofen

Product NDC
68071-3442
11-digit product format
680713442
Labeler code
68071
Product ID
68071-3442_29a54361-e109-20d7-e063-6294a90a117a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA213794
Marketing category
ANDA
Marketing start
2020-05-08
Substance
IBUPROFEN
Active strength
400 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213794-001IBUPROFENIBUPROFEN400MGTABLET / ORALAB2020-05-08
A213794-002IBUPROFENIBUPROFEN600MGTABLET / ORALAB2020-05-08
A213794-003IBUPROFENIBUPROFEN800MGTABLET / ORALAB2020-05-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A213794-001AB
A213794-002AB
A213794-003AB

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 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213794-001IBUPROFEN400MGTABLET / ORALAB2020-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213794-002IBUPROFEN600MGTABLET / ORALAB2020-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213794-003IBUPROFEN800MGTABLET / ORALAB2020-05-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213794-001IBUPROFEN400MGTABLET / ORALAB2020-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213794-002IBUPROFEN600MGTABLET / ORALAB2020-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213794-003IBUPROFEN800MGTABLET / ORALAB2020-05-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A213794-001IBUPROFEN400MGTABLET / ORALAB2020-05-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213794-002IBUPROFEN600MGTABLET / ORALAB2020-05-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213794-003IBUPROFEN800MGTABLET / ORALAB2020-05-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213794-001IBUPROFEN400MGTABLET / ORALAB2020-05-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213794-002IBUPROFEN600MGTABLET / ORALAB2020-05-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213794-003IBUPROFEN800MGTABLET / ORALAB2020-05-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213794-001IBUPROFEN400MGTABLET / ORALAB2020-05-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213794-002IBUPROFEN600MGTABLET / ORALAB2020-05-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213794-003IBUPROFEN800MGTABLET / ORALAB2020-05-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213794-001IBUPROFEN400MGTABLET / ORALAB2020-05-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213794-002IBUPROFEN600MGTABLET / ORALAB2020-05-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213794-003IBUPROFEN800MGTABLET / ORALAB2020-05-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213794-001IBUPROFEN400MGTABLET / ORALAB2020-05-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213794-002IBUPROFEN600MGTABLET / ORALAB2020-05-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213794-003IBUPROFEN800MGTABLET / ORALAB2020-05-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213794-001IBUPROFEN400MGTABLET / ORALAB2020-05-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213794-002IBUPROFEN600MGTABLET / ORALAB2020-05-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213794-003IBUPROFEN800MGTABLET / ORALAB2020-05-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213794-001IBUPROFEN400MGTABLET / ORALAB2020-05-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213794-002IBUPROFEN600MGTABLET / ORALAB2020-05-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213794-003IBUPROFEN800MGTABLET / ORALAB2020-05-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213794-001IBUPROFEN400MGTABLET / ORALAB2020-05-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A213794-002IBUPROFEN600MGTABLET / ORALAB2020-05-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A213794-003IBUPROFEN800MGTABLET / ORALAB2020-05-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213794-001IBUPROFEN400MGTABLET / ORALAB2020-05-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213794-002IBUPROFEN600MGTABLET / ORALAB2020-05-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213794-003IBUPROFEN800MGTABLET / ORALAB2020-05-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213794-001IBUPROFEN400MGTABLET / ORALAB2020-05-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213794-002IBUPROFEN600MGTABLET / ORALAB2020-05-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213794-003IBUPROFEN800MGTABLET / ORALAB2020-05-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213794-001IBUPROFEN400MGTABLET / ORALAB2020-05-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213794-002IBUPROFEN600MGTABLET / ORALAB2020-05-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213794-003IBUPROFEN800MGTABLET / ORALAB2020-05-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213794-001IBUPROFEN400MGTABLET / ORALAB2020-05-088072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213794-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213794-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213794-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213794-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213794-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213794-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213794-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213794-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213794-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213794-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213794-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213794-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213794-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213794-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213794-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213794-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213794-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213794-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213794-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213794-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213794-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213794-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213794-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213794-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213794-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213794-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213794-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213794-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213794-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213794-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213794-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213794-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213794-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213794-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213794-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213794-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213794-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213794-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213794-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213794-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN400 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
197805Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe939219-d752-63a0-e053-6394a90a0ab2Available 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
68071-3442-2Ibuprofen20 in 1 BOTTLETABLET203
68071-3442-3Ibuprofen30 in 1 BOTTLETABLET303
68071-3442-9Ibuprofen90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3442IBUPROFEN TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, 3 package rows20241222_fe939219-d752-63a0-e053-6394a90a0ab2.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 2 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENSt. Mary's Medical Park Pharmacy0a98cce4-f5c0-12a8-e063-6294a90a4e7e2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794
IbuprofenIBUPROFENProficient Rx LP34a9b94f-93ba-4a7c-92eb-d0b4b530d8872026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794
IbuprofenIBUPROFENHAWAII REPACK, INC.6239818c-747d-4cbb-9b41-27ca8bbce41b2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794
IbuprofenIBUPROFENSportpharm LLCcef04ae4-e78a-454d-bb66-84b1d348c1062026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794
IbuprofenIBUPROFENUnit Dose Solutions, Inc.5515e80f-7513-b425-e063-6294a90aa5422026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794
IbuprofenIBUPROFENREMEDYREPACK INC.2fa4bfc8-386c-433b-bc46-24fc8ec1bca12026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794
IbuprofenIBUPROFENREMEDYREPACK INC.ec6b2df4-2f4f-4601-8b53-0542664e0bd92026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.bdc3f482-6fba-4420-9118-0f5cb7744e972026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.13fd4401-1821-4f2b-a44e-96aa2fa75b5c2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.25d9f5fc-4d95-4018-add8-ba696b6079b22026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.05ce8e8e-0b25-061e-e063-6394a90a2e922026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794
IbuprofenIBUPROFENCoupler LLC50766a3d-1a22-be14-e063-6294a90a0ed22026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794
IbuprofenIBUPROFENNorthStar Rx LLCaeee629b-255c-40d8-8e95-779aec00f7232026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794
IbuprofenIBUPROFENDirect_Rx1aa11b52-1aca-9219-e063-6294a90a470f2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794
IbuprofenIBUPROFENA-S Medication Solutionsf24582be-8d70-4848-bd54-e55fa28f394f2025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794
IbuprofenIBUPROFENA-S Medication Solutionse5db46f3-043b-40ac-a89b-c90bd562e7b42025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794
IbuprofenIBUPROFENA-S Medication Solutions3db0c659-cc43-45dc-8442-bc89093d94d72025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.f60445d3-807e-0bbf-e053-2995a90a12992025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794
IbuprofenIBUPROFENA-S Medication Solutions8d5f7d2a-af48-4d47-8bf5-48f01c092d242025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794
IbuprofenIBUPROFENA-S Medication Solutions4b75bd6f-5455-4237-991c-eacc0fdcf7092025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213794
application number: ANDA213794

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNfe939219-d752-63a0-e053-6394a90a0ab23
197805ibuprofen 400 MG Oral TabletSCDfe939219-d752-63a0-e053-6394a90a0ab23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3442-26807134420220 TABLET in 1 BOTTLE (68071-3442-2) 20 tablet2024-12-19NoNoCurrent
68071-3442-36807134420330 TABLET in 1 BOTTLE (68071-3442-3) 30 tablet2023-06-20NoNoCurrent
68071-3442-96807134420990 TABLET in 1 BOTTLE (68071-3442-9) 90 tablet2023-06-20NoNoCurrent