Ibuprofen and famotidine

Product NDC
63629-8891
11-digit product format
636298891
Labeler code
63629
Product ID
63629-8891_eecdc3bf-cc98-4db0-a94f-7ba1b1830548
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen and famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
63629-8891-1Ibuprofen and famotidine30 in 1 BOTTLETABLET, FILM COATED30106
63629-8891-2Ibuprofen and famotidine90 in 1 BOTTLETABLET, FILM COATED90106
63629-8891-3Ibuprofen and famotidine60 in 1 BOTTLETABLET, FILM COATED60106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8891-1EA - Each63629-8891a303cb2c-8eb6-4b11-a3ff-1d6b4a0b2ff412022-08-04
63629-8891-2EA - Each63629-889118497cf9-ad7b-45a9-9a8d-38768794425412022-08-04
63629-8891-3EA - Each63629-889191ce36cc-c45e-4a68-aef3-f6db0d3a631d12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8891IBUPROFEN AND FAMOTIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 3 package rows20241024_ee69d3cb-dc95-410c-a7c8-6623073a923d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100066ibuprofen 800 MG / famotidine 26.6 MG Oral TabletPSNee69d3cb-dc95-410c-a7c8-6623073a923d106
1100066famotidine 26.6 MG / ibuprofen 800 MG Oral TabletSCDee69d3cb-dc95-410c-a7c8-6623073a923d106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8891-16362988910130 TABLET, FILM COATED in 1 BOTTLE (63629-8891-1) 2021-10-260000-00-00NoNoCurrent
63629-8891-26362988910290 TABLET, FILM COATED in 1 BOTTLE (63629-8891-2) 2022-04-080000-00-00NoNoCurrent
63629-8891-36362988910360 TABLET, FILM COATED in 1 BOTTLE (63629-8891-3) 2023-09-15NoNoHistorical