FDA.reportPublic FDA data

Ibuprofen and famotidine

Product NDC
85509-1626
11-digit product format
855091626
Labeler code
85509
Product ID
85509-1626_4ee3e858-3e4f-85de-e063-6394a90a21a0
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen and famotidine
Listing expiration
2027-12-31

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
85509-1626-3Ibuprofen and famotidine30 in 1 BOTTLETABLET, FILM COATED301
85509-1626-6Ibuprofen and famotidine60 in 1 BOTTLETABLET, FILM COATED601
85509-1626-9Ibuprofen and famotidine90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1626-3EA - Each85509-162615ee8931-6876-411e-b6ab-8cc4547855ce12026-05-22
85509-1626-6EA - Each85509-1626106b2615-55ab-4c9f-8c84-7a376938e5bd12026-05-22
85509-1626-9EA - Each85509-1626466b9597-171d-4645-b3b7-13509c48e93412026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100066ibuprofen 800 MG / famotidine 26.6 MG Oral TabletPSN4ee3e849-2197-8883-e063-6394a90a17481
1100066famotidine 26.6 MG / ibuprofen 800 MG Oral TabletSCD4ee3e849-2197-8883-e063-6394a90a17481

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85509-1626-38550916260330 TABLET, FILM COATED in 1 BOTTLE (85509-1626-3) 2026-04-07NoNoHistorical
85509-1626-68550916260660 TABLET, FILM COATED in 1 BOTTLE (85509-1626-6) 2026-04-07NoNoHistorical
85509-1626-98550916260990 TABLET, FILM COATED in 1 BOTTLE (85509-1626-9) 2026-04-07NoNoHistorical