FDA.reportPublic FDA data

Acid Controller

Product NDC
0363-0701
11-digit product format
003630701
Labeler code
0363
Product ID
0363-0701_66b3969f-1536-48ad-9e8b-5a25f5eb1c5e
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
ANDA077351
Marketing category
ANDA
Marketing start
2006-09-26
Substance
FAMOTIDINE
Active strength
20 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
Acid Controller
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FAMOTIDINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QZO15J2Z8
Rxcui310273

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
0363-0701-01Acid Controller85 in 1 BOTTLETABLET, FILM COATED8511
0363-0701-01Acid Controller1 in 1 CARTONTABLET, FILM COATED111
0363-0701-02Acid Controller25 in 1 CARTONTABLET, FILM COATED2511
0363-0701-02Acid Controller1 in 1 BLISTER PACKTABLET, FILM COATED111
0363-0701-39Acid Controller1 in 1 BLISTER PACKTABLET, FILM COATED111
0363-0701-39Acid Controller30 in 1 CARTONTABLET, FILM COATED3011
0363-0701-71Acid Controller1 in 1 CARTONTABLET, FILM COATED111
0363-0701-71Acid Controller50 in 1 BOTTLETABLET, FILM COATED5011
0363-0701-72Acid Controller1 in 1 CARTONTABLET, FILM COATED111
0363-0701-72Acid Controller60 in 1 BOTTLETABLET, FILM COATED6011
0363-0701-82Acid Controller1 in 1 CARTONTABLET, FILM COATED111
0363-0701-82Acid Controller200 in 1 BOTTLETABLET, FILM COATED20011
0363-0701-98Acid Controller75 in 1 BOTTLETABLET, FILM COATED7511
0363-0701-98Acid Controller1 in 1 CARTONTABLET, FILM COATED111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0701-71EA - Each0363-0701a00262d0-11e5-4373-b42f-81949815b74812022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8ACID CONTROLLER (FAMOTIDINE) TABLET [WALGREEN COMPANY]2
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8ACID CONTROLLER (FAMOTIDINE) TABLET [WALGREEN COMPANY]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZACID CONTROLLER (FAMOTIDINE) TABLET [WALGREEN COMPANY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACID CONTROLLER (FAMOTIDINE) TABLET [WALGREEN COMPANY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACID CONTROLLER (FAMOTIDINE) TABLET [WALGREEN COMPANY]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACID CONTROLLER (FAMOTIDINE) TABLET [WALGREEN COMPANY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACID CONTROLLER (FAMOTIDINE) TABLET [WALGREEN COMPANY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACID CONTROLLER (FAMOTIDINE) TABLET [WALGREEN COMPANY]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ACID CONTROLLER (FAMOTIDINE) TABLET [WALGREEN COMPANY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACID CONTROLLER (FAMOTIDINE) TABLET [WALGREEN COMPANY]2
TALCINACTIVE INGREDIENT7SEV7J4R1UACID CONTROLLER (FAMOTIDINE) TABLET [WALGREEN COMPANY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACID CONTROLLER (FAMOTIDINE) TABLET [WALGREEN COMPANY]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSN42392cb1-7958-4a2f-8622-f00f02afd96111
310273famotidine 20 MG Oral TabletSCD42392cb1-7958-4a2f-8622-f00f02afd96111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0701-01003630701011 BOTTLE in 1 CARTON (0363-0701-01) > 85 TABLET, FILM COATED in 1 BOTTLE1 bottle2007-10-290000-00-00NoNoCurrent
0363-0701-020036307010225 BLISTER PACK in 1 CARTON (0363-0701-02) > 1 TABLET, FILM COATED in 1 BLISTER PACK25 blister pack2006-09-260000-00-00NoNoCurrent
0363-0701-39003630701391 in 1 BLISTER PACKHistorical
0363-0701-71003630701711 BOTTLE in 1 CARTON (0363-0701-71) > 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2006-09-260000-00-00NoNoCurrent
0363-0701-72003630701721 BOTTLE in 1 CARTON (0363-0701-72) > 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2011-06-020000-00-00NoNoCurrent
0363-0701-82003630701821 BOTTLE in 1 CARTON (0363-0701-82) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-05-080000-00-00NoNoCurrent
0363-0701-98003630701981 BOTTLE in 1 CARTON (0363-0701-98) / 75 TABLET, FILM COATED in 1 BOTTLE1 bottle2026-03-13NoNoCurrent