good sense ibuprofen

Product NDC
68788-4051
Requested package NDC
68788-4051-5
11-digit product format
687884051
Labeler code
68788
Product ID
68788-4051_c447fc6b-e9ef-447a-9609-5f893e18dfa7
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA072096
Marketing category
ANDA
Marketing start
2025-11-17
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
A072096-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1987-12-08

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
2026-08-01 22:54:322026-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 4 · 67 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPROFENIBUPROFENAmazon.com Services LLCb5a47efe-222f-4cbd-b649-caafd16a08292026-07-29WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENHyVee Ince7175dc9-db39-4452-a419-85af179de4222026-07-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENBryant Ranch Prepackd6460cc3-c207-44e0-bf78-ad6fef055ed52026-07-09WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENUnit Dose Solutions, Inc.551535ce-eab0-bb13-e063-6294a90a20702026-06-25WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Berkley and Jensen IbuprofenIBUPROFENBJWCcda57e42-6106-46ee-82d1-479a692ee5bb2026-05-21WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen085dcc1a-e4b0-4d08-9476-72275382d1a12026-05-15WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENPreferred Pharmaceuticals Inc.f1a03b1f-2d87-43cc-b256-bd296ccd09f22026-05-13WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENKroger Company6307485a-8be6-40ee-899b-00eb3ee8ce612026-05-01WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
CounterAct IBIBUPROFENMelaleuca, Inc7fafc13e-3fee-ace3-e053-2a91aa0ac2ea2026-03-17Boxed warning, WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leaderd673266c-3d2b-479f-9b53-cdd1b86513932026-02-25WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENHyVee Inc4c24c884-55f7-40b4-8d6f-db6144d5ebcb2026-02-05WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENHyVee Inc5233c409-3743-4312-9f75-14ded6755b5c2026-02-02WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
equate ibuprofenIBUPROFENWal-Mart Stores Incb29034a6-657b-426f-a41a-5e64c4bc759d2026-01-20WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENCVS Pharmacyace493e6-91bc-41aa-8e5c-5bc14981de912026-01-06WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENNorthwind Health Company, LLCda6c2802-5d15-dbcb-e053-2a95a90a25612026-01-01WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENL. Perrigo Company70d0a429-27c1-43a5-b2ea-a9919e0910f82025-12-22WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENNuCare Pharmaceuticals, Inc.463ea713-6b27-b00b-e063-6394a90a86462025-12-18WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.96bff700-bca3-4b94-b8a2-379102721db82025-12-15WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENPreferred Pharmaceuticals Inc.c447fc6b-e9ef-447a-9609-5f893e18dfa72025-11-17WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (package): 68788-4051-5
ndc (product): 68788-4051
ndc11 (package): 68788405105
GOODNOW PAIN RELIEFIBUPROFENGobrands, Inc0759085d-6ac3-446b-ac2c-8dc30e32e1d12025-11-08WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096

Additional Listing Data#

Finished product
Yes
Brand name base
good sense ibuprofen
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
c447fc6b-e9ef-447a-9609-5f893e18dfa7Available 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
68788-4051-1good sense ibuprofen100 in 1 BOTTLETABLET, FILM COATED1001
68788-4051-3good sense ibuprofen30 in 1 BOTTLETABLET, FILM COATED301
68788-4051-5good sense ibuprofen50 in 1 BOTTLETABLET, FILM COATED501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4051-1EA - Each68788-4051fda2f448-00aa-46bb-84c1-e0ff3b89d17612026-01-08
68788-4051-3EA - Each68788-405104bf60db-e46f-43df-8e44-8f14434d4a1212026-01-08
68788-4051-5EA - Each68788-405147765d1f-5e23-4344-8080-47e2f2c1904712026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNc447fc6b-e9ef-447a-9609-5f893e18dfa71
310965ibuprofen 200 MG Oral TabletSCDc447fc6b-e9ef-447a-9609-5f893e18dfa71
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYc447fc6b-e9ef-447a-9609-5f893e18dfa71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-4051-56878840510550 TABLET, FILM COATED in 1 BOTTLE (68788-4051-5) 2025-11-17NoNoCurrent