FDA.reportPublic FDA data

acid controller

Product NDC
37808-301
11-digit product format
378080301
Labeler code
37808
Product ID
37808-301_baac0d4f-1e8d-4ce2-ab82-5906c63c8654
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H E B
Application
ANDA075400
Marketing category
ANDA
Marketing start
2015-10-23
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
acid controller
Listing expiration
2026-12-31

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
37808-301-65acid controller30 in 1 CARTONTABLET, FILM COATED309
37808-301-65acid controller1 in 1 BLISTER PACKTABLET, FILM COATED19
37808-301-72acid controller60 in 1 BOTTLETABLET, FILM COATED609
37808-301-72acid controller1 in 1 CARTONTABLET, FILM COATED19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8ACID CONTROLLER (FAMOTIDINE) TABLET [H E B]2
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8ACID CONTROLLER (FAMOTIDINE) TABLET [H E B]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZACID CONTROLLER (FAMOTIDINE) TABLET [H E B]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACID CONTROLLER (FAMOTIDINE) TABLET [H E B]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ACID CONTROLLER (FAMOTIDINE) TABLET [H E B]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTACID CONTROLLER (FAMOTIDINE) TABLET [H E B]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACID CONTROLLER (FAMOTIDINE) TABLET [H E B]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACID CONTROLLER (FAMOTIDINE) TABLET [H E B]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEACID CONTROLLER (FAMOTIDINE) TABLET [H E B]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACID CONTROLLER (FAMOTIDINE) TABLET [H E B]2
TALCINACTIVE INGREDIENT7SEV7J4R1UACID CONTROLLER (FAMOTIDINE) TABLET [H E B]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACID CONTROLLER (FAMOTIDINE) TABLET [H E B]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ACID CONTROLLER (FAMOTIDINE) TABLET [H E B]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-301ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [H E B]8Current NDC, Legacy NDC, 4 package rows20250211_813d742f-8f3d-4f18-a6c5-03eea946f976.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN813d742f-8f3d-4f18-a6c5-03eea946f9769
199047famotidine 10 MG Oral TabletSCD813d742f-8f3d-4f18-a6c5-03eea946f9769

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-301-653780803016530 BLISTER PACK in 1 CARTON (37808-301-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2015-10-230000-00-00NoNoCurrent
37808-301-72378080301721 BOTTLE in 1 CARTON (37808-301-72) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-10-230000-00-00NoNoCurrent