FDA.reportPublic FDA data

Ibuprofen and Famotidine

Product NDC
72578-214
Requested package NDC
72578-214-16
11-digit product format
725780214
Labeler code
72578
Product ID
72578-214_d0498b4c-d60a-4a93-b151-d3bc4658787a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen and Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA218684
Marketing category
ANDA
Marketing start
2025-06-01
Substance
IBUPROFEN; FAMOTIDINE
Active strength
800; 26.6 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], 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 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
A218684-001IBUPROFEN AND FAMOTIDINEFAMOTIDINE; IBUPROFEN26.6MG;800MGTABLET / ORALAB2025-02-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218684-001AB

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 22:38:342026-08A218684-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2025-02-2084e616aacf4f…
2026-08-18 06:07:402026-07A218684-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2025-02-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218684-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2025-02-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218684-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2025-02-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A218684-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2025-02-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218684-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2025-02-20fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218684-001IBUPROFEN AND FAMOTIDINE26.6MG;800MGTABLET / ORALAB2025-02-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218684-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A218684-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218684-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218684-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218684-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218684-001AB1fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218684-001AB1a50c72e98297…

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 and Famotidine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN800 mg/1
FAMOTIDINE26.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup
5QZO15J2Z8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1100066Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
66524c84-35bc-4e7f-897a-f63fa4bca432Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
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
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72578-214-16Ibuprofen and Famotidine90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-214-16EA - Each72578-21473d594bb-6c0a-4eeb-bcf2-e790894a189e12026-03-17

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen FamotidineIBUPROFEN FAMOTIDINEDirect_Rx54d9e1fc-507d-1859-e063-6394a90a8c6b2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218684
application number: ANDA218684
Ibuprofen and FamotidineIBUPROFEN AND FAMOTIDINEAdvanced Rx of Tennessee, LLC548c705e-4094-fc6f-e063-6394a90a34262026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218684
application number: ANDA218684
Ibuprofen and FamotidineIBUPROFEN AND FAMOTIDINEZydus Lifesciences Limited24204938-0989-42ad-8ad8-89979e62d7002025-05-28Exact identifier
application applno (ANDA): 218684
application number: ANDA218684
Ibuprofen and FamotidineIBUPROFEN AND FAMOTIDINEViona Pharmaceuticals Inc66524c84-35bc-4e7f-897a-f63fa4bca4322025-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218684
application number: ANDA218684
ndc (package): 72578-214-16
ndc (product): 72578-214
ndc11 (package): 72578021416

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100066ibuprofen 800 MG / famotidine 26.6 MG Oral TabletPSN66524c84-35bc-4e7f-897a-f63fa4bca4321
1100066famotidine 26.6 MG / ibuprofen 800 MG Oral TabletSCD66524c84-35bc-4e7f-897a-f63fa4bca4321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72578-214-167257802141690 TABLET in 1 BOTTLE (72578-214-16) 90 tablet2025-06-01NoNoCurrent