FDA.reportPublic FDA data

Acid Controller

Product NDC
0363-0141
11-digit product format
003630141
Labeler code
0363
Product ID
0363-0141_a76613fb-27ac-4c92-86c0-220e9ae06c55
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
ANDA075400
Marketing category
ANDA
Marketing start
2009-08-28
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
Acid Controller
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
0363-0141-39Acid ControllerOriginal Strength1 in 1 CARTONTABLET, FILM COATED18
0363-0141-39Acid ControllerOriginal Strength30 in 1 BOTTLETABLET, FILM COATED308
0363-0141-48Acid ControllerOriginal Strength2 in 1 CARTONTABLET, FILM COATED28
0363-0141-48Acid ControllerOriginal Strength90 in 1 BOTTLETABLET, FILM COATED908
0363-0141-65Acid ControllerOriginal Strength1 in 1 BLISTER PACKTABLET, FILM COATED18
0363-0141-65Acid ControllerOriginal Strength30 in 1 CARTONTABLET, FILM COATED308
0363-0141-75Acid ControllerOriginal Strength1 in 1 CARTONTABLET, FILM COATED18
0363-0141-75Acid ControllerOriginal Strength90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0141-65EA - Each0363-0141c21cdea7-b001-4e9d-8b88-19ebf09ebfac12022-06-06
0363-0141-75EA - Each0363-014134c973ab-b543-4812-aec4-b1f326118ca212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8ACID CONTROLLER ORIGINAL STRENGTH (FAMOTIDINE) TABLET [WALGREEN COMPANY]1
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8ACID CONTROLLER ORIGINAL STRENGTH (FAMOTIDINE) TABLET [WALGREEN COMPANY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACID CONTROLLER ORIGINAL STRENGTH (FAMOTIDINE) TABLET [WALGREEN COMPANY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACID CONTROLLER ORIGINAL STRENGTH (FAMOTIDINE) TABLET [WALGREEN COMPANY]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN98c6ddc9-8103-40b3-a145-ffbe3374ab6c8
199047famotidine 10 MG Oral TabletSCD98c6ddc9-8103-40b3-a145-ffbe3374ab6c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0141-39003630141391 BOTTLE in 1 CARTON (0363-0141-39) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2026-01-16NoNoHistorical
0363-0141-48003630141482 BOTTLE in 1 CARTON (0363-0141-48) / 90 TABLET, FILM COATED in 1 BOTTLE2 bottle2025-12-12NoNoHistorical
0363-0141-650036301416530 BLISTER PACK in 1 CARTON (0363-0141-65) > 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2009-11-250000-00-00NoNoCurrent
0363-0141-75003630141751 BOTTLE in 1 CARTON (0363-0141-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-08-280000-00-00NoNoCurrent