FDA.reportPublic FDA data

Ibuprofen and Famotidine

Product NDC
80425-0587
Requested package NDC
80425-0587-3
11-digit product format
804250587
Labeler code
80425
Product ID
80425-0587_548c6ccd-7c02-f53f-e063-6394a90a7aaf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen and Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA218684
Marketing category
ANDA
Marketing start
2026-06-18
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
2027-12-31
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
2027-12-31

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
548c705e-4094-fc6f-e063-6394a90a3426Available on FDA.report

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
ndc (package): 80425-0587-3
ndc (product): 80425-0587
ndc11 (package): 80425058703
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0587-38042505870390 TABLET in 1 BOTTLE (80425-0587-3) 90 tablet2026-06-18NoNoCurrent