FDA.reportPublic FDA data

Ibuprofen and famotidine

Product NDC
85509-1010
11-digit product format
855091010
Labeler code
85509
Product ID
85509-1010_39a9d46c-6833-d3cc-e063-6394a90adfe3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen and famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PHOENIX RX LLC
Application
ANDA211890
Marketing category
ANDA
Marketing start
2021-08-04
Substance
FAMOTIDINE; IBUPROFEN
Active strength
26.6; 800 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

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8, WK2XYI10QM
Rxcui1100066

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
85509-1010-3Ibuprofen and famotidine30 in 1 BOTTLETABLET, FILM COATED303
85509-1010-6Ibuprofen and famotidine60 in 1 BOTTLETABLET, FILM COATED603
85509-1010-9Ibuprofen and famotidine90 in 1 BOTTLETABLET, FILM COATED903

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100066ibuprofen 800 MG / famotidine 26.6 MG Oral TabletPSN397f1f23-10c2-569e-e063-6394a90a71643
1100066famotidine 26.6 MG / ibuprofen 800 MG Oral TabletSCD397f1f23-10c2-569e-e063-6394a90a71643

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85509-1010-38550910100330 TABLET, FILM COATED in 1 BOTTLE (85509-1010-3) 2025-07-21NoNoCurrent
85509-1010-68550910100660 TABLET, FILM COATED in 1 BOTTLE (85509-1010-6) 2025-07-21NoNoCurrent
85509-1010-98550910100990 TABLET, FILM COATED in 1 BOTTLE (85509-1010-9) 2025-07-21NoNoCurrent