FDA.reportPublic FDA data

Ibuprofen and famotidine

Product NDC
76420-891
11-digit product format
764200891
Labeler code
76420
Product ID
76420-891_2abbd7c9-640f-d0cb-e063-6294a90a23f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen and famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
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
76420-891-01Ibuprofen and famotidine100 in 1 BOTTLETABLET, FILM COATED1001
76420-891-05Ibuprofen and famotidine500 in 1 BOTTLETABLET, FILM COATED5001
76420-891-06Ibuprofen and famotidine6 in 1 CARTONTABLET, FILM COATED61
76420-891-06Ibuprofen and famotidine1 in 1 BLISTER PACKTABLET, FILM COATED11
76420-891-30Ibuprofen and famotidine30 in 1 BOTTLETABLET, FILM COATED301
76420-891-60Ibuprofen and famotidine60 in 1 BOTTLETABLET, FILM COATED601
76420-891-90Ibuprofen and famotidine90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-891-01EA - Each76420-89117f09841-3eb1-452f-a4c7-c18bf0fcd80c12026-04-20
76420-891-05EA - Each76420-89120ea9806-39f3-4fff-a451-4bb55d5f9d1d12026-04-20
76420-891-06EA - Each76420-891bbfe4733-67a1-483d-b99e-3b7b2e41f73f12026-04-20
76420-891-30EA - Each76420-891fb3b97bf-c3b1-4ae2-b0f6-785077ebc82b12026-04-20
76420-891-60EA - Each76420-89139dc1ec9-0461-447b-bb91-b5dac17b7e4012026-04-20
76420-891-90EA - Each76420-891b3938413-4617-457a-8cac-34c12a3c023e12026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-891IBUPROFEN AND FAMOTIDINE TABLET, FILM COATED [ASCLEMED USA, INC.]1Current NDC, 7 package rows20250104_41123df3-97ac-4c4f-9a89-f76ec03898bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100066ibuprofen 800 MG / famotidine 26.6 MG Oral TabletPSN41123df3-97ac-4c4f-9a89-f76ec03898bb1
1100066famotidine 26.6 MG / ibuprofen 800 MG Oral TabletSCD41123df3-97ac-4c4f-9a89-f76ec03898bb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-891-0176420089101100 TABLET, FILM COATED in 1 BOTTLE (76420-891-01) 2025-01-02NoNoHistorical
76420-891-0576420089105500 TABLET, FILM COATED in 1 BOTTLE (76420-891-05) 2025-01-02NoNoHistorical
76420-891-06764200891066 BLISTER PACK in 1 CARTON (76420-891-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2025-01-02NoNoHistorical
76420-891-307642008913030 TABLET, FILM COATED in 1 BOTTLE (76420-891-30) 2025-01-02NoNoHistorical
76420-891-607642008916060 TABLET, FILM COATED in 1 BOTTLE (76420-891-60) 2025-01-02NoNoHistorical
76420-891-907642008919090 TABLET, FILM COATED in 1 BOTTLE (76420-891-90) 2025-01-02NoNoHistorical