heartburn relief

Product NDC
0904-5529
11-digit product format
009045529
Labeler code
0904
Product ID
0904-5529_4bbca900-8593-427c-8595-c5c6c3456967
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA075400
Marketing category
ANDA
Marketing start
2009-09-09
Substance
FAMOTIDINE
Active strength
10 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
heartburn relief
Brand name suffix
original strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui199047

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
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-5529-52heartburn relieforiginal strength60 in 1 BOTTLETABLET, FILM COATED609
0904-5529-52heartburn relieforiginal strength1 in 1 CARTONTABLET, FILM COATED19
0904-5529-87heartburn relieforiginal strength30 in 1 CARTONTABLET, FILM COATED309
0904-5529-87heartburn relieforiginal strength1 in 1 BLISTER PACKTABLET, FILM COATED19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5529-52EA - Each0904-552993b6fd11-9755-48a9-9f80-c3f968c2e6ee12012-07-24
0904-5529-87EA - Each0904-552924b18c99-1a6b-435d-ac55-cd5383f339f712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8HEARTBURN RELIEF ORIGINAL STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]3
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8HEARTBURN RELIEF ORIGINAL STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHEARTBURN RELIEF ORIGINAL STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHEARTBURN RELIEF ORIGINAL STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675HEARTBURN RELIEF ORIGINAL STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTHEARTBURN RELIEF ORIGINAL STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHEARTBURN RELIEF ORIGINAL STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HEARTBURN RELIEF ORIGINAL STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEHEARTBURN RELIEF ORIGINAL STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHEARTBURN RELIEF ORIGINAL STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]3
TALCINACTIVE INGREDIENT7SEV7J4R1UHEARTBURN RELIEF ORIGINAL STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHEARTBURN RELIEF ORIGINAL STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]3
TRIACETININACTIVE INGREDIENTXHX3C3X673HEARTBURN RELIEF ORIGINAL STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5529HEARTBURN RELIEF ORIGINAL STRENGTH (FAMOTIDINE) TABLET [MAJOR PHARMACEUTICALS]7Current NDC, Legacy NDC, 4 package rows20250209_be275c48-18bf-45f6-891d-36d89327813e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSNbe275c48-18bf-45f6-891d-36d89327813e9
199047famotidine 10 MG Oral TabletSCDbe275c48-18bf-45f6-891d-36d89327813e9
199047famotidine 10 MG Oral TabletPSN5567aaaf-b4f2-4604-b841-c9447e77256c3
199047famotidine 10 MG Oral TabletSCD5567aaaf-b4f2-4604-b841-c9447e77256c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5529-52009045529521 BOTTLE in 1 CARTON (0904-5529-52) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-09-090000-00-00NoNoCurrent
0904-5529-870090455298730 BLISTER PACK in 1 CARTON (0904-5529-87) / 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2009-09-090000-00-00NoNoCurrent