TopCare Acid Reducer

Product NDC
36800-141
11-digit product format
368000141
Labeler code
36800
Product ID
36800-141_c15b21b3-6e50-4ed4-90ef-28483e1cf535
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA075400
Marketing category
ANDA
Marketing start
2009-09-11
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
TopCare Acid Reducer
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
36800-141-65TopCare Acid Reducer1 in 1 BLISTER PACKTABLET, FILM COATED19
36800-141-65TopCare Acid Reducer30 in 1 CARTONTABLET, FILM COATED309
36800-141-72TopCare Acid Reducer60 in 1 BOTTLETABLET, FILM COATED609
36800-141-72TopCare Acid Reducer1 in 1 CARTONTABLET, FILM COATED19
36800-141-75TopCare Acid Reducer1 in 1 CARTONTABLET, FILM COATED19
36800-141-75TopCare Acid Reducer90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-141TOPCARE ACID REDUCER (FAMOTIDINE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]8Current NDC, Legacy NDC, 6 package rows20250214_88722f84-dac8-4130-93b3-9e0dc1cc5acc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN88722f84-dac8-4130-93b3-9e0dc1cc5acc9
199047famotidine 10 MG Oral TabletSCD88722f84-dac8-4130-93b3-9e0dc1cc5acc9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-141-653680001416530 BLISTER PACK in 1 CARTON (36800-141-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2009-10-130000-00-00NoNoCurrent
36800-141-72368000141721 BOTTLE in 1 CARTON (36800-141-72) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-09-110000-00-00NoNoCurrent
36800-141-75368000141751 BOTTLE in 1 CARTON (36800-141-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-03-220000-00-00NoNoCurrent