FDA.reportPublic FDA data

TopCare Acid Reducer

Product NDC
36800-194
11-digit product format
368000194
Labeler code
36800
Product ID
36800-194_4f159fc7-8379-465d-9a92-d3c8bffefdc6
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA077351
Marketing category
ANDA
Marketing start
2006-09-28
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TopCare Acid Reducer
Listing expiration
2026-12-31

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
36800-194-02TopCare Acid Reducer25 in 1 CARTONTABLET, FILM COATED2510
36800-194-02TopCare Acid Reducer1 in 1 BLISTER PACKTABLET, FILM COATED110
36800-194-51TopCare Acid Reducer8 in 1 CARTONTABLET, FILM COATED810
36800-194-51TopCare Acid Reducer1 in 1 BLISTER PACKTABLET, FILM COATED110
36800-194-71TopCare Acid Reducer1 in 1 CARTONTABLET, FILM COATED110
36800-194-71TopCare Acid Reducer50 in 1 BOTTLETABLET, FILM COATED5010
36800-194-78TopCare Acid Reducer100 in 1 BOTTLETABLET, FILM COATED10010
36800-194-78TopCare Acid Reducer1 in 1 CARTONTABLET, FILM COATED110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-194TOPCARE ACID REDUCER (FAMOTIDINE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]9Current NDC, Legacy NDC, 8 package rows20250213_c3c9ae86-f6d7-4a6c-a991-be8ef7c6adbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310273famotidine 20 MG Oral TabletPSNc3c9ae86-f6d7-4a6c-a991-be8ef7c6adbe10
310273famotidine 20 MG Oral TabletSCDc3c9ae86-f6d7-4a6c-a991-be8ef7c6adbe10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-194-023680001940225 BLISTER PACK in 1 CARTON (36800-194-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK25 blister pack2006-09-280000-00-00NoNoCurrent
36800-194-51368000194518 BLISTER PACK in 1 CARTON (36800-194-51) > 1 TABLET, FILM COATED in 1 BLISTER PACK8 blister pack2006-10-160000-00-00NoNoCurrent
36800-194-71368000194711 BOTTLE in 1 CARTON (36800-194-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2006-10-160000-00-00NoNoCurrent
36800-194-78368000194781 BOTTLE in 1 CARTON (36800-194-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-02-020000-00-00NoNoCurrent