FDA.reportPublic FDA data

Calmicid AC

Product NDC
54473-203
11-digit product format
544730203
Labeler code
54473
Product ID
54473-203_f179ab4b-656d-2001-e053-2a95a90a749e
Type
HUMAN OTC DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Melaleuca, Inc.
Application
ANDA090283
Marketing category
ANDA
Marketing start
2011-01-20
Marketing end
0000-00-00
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
2024-12-31
Current FDA listing
Historical FDA.report record

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
54473-203-01Calmicid ACAcid Reducer50 in 1 BOTTLETABLET, FILM COATED507
54473-203-50Calmicid ACAcid Reducer1 in 1 BOXTABLET, FILM COATED17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8CALMICID AC ACID REDUCER (LORATADINE) TABLET, FILM COATED [MELALEUCA, INC.]2
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8CALMICID AC ACID REDUCER (LORATADINE) TABLET, FILM COATED [MELALEUCA, INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCALMICID AC ACID REDUCER (LORATADINE) TABLET, FILM COATED [MELALEUCA, INC.]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UCALMICID AC ACID REDUCER (LORATADINE) TABLET, FILM COATED [MELALEUCA, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CALMICID AC ACID REDUCER (LORATADINE) TABLET, FILM COATED [MELALEUCA, INC.]2
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCALMICID AC ACID REDUCER (LORATADINE) TABLET, FILM COATED [MELALEUCA, INC.]2
Magnesium stearateINACTIVE INGREDIENT70097M6I30CALMICID AC ACID REDUCER (LORATADINE) TABLET, FILM COATED [MELALEUCA, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACALMICID AC ACID REDUCER (LORATADINE) TABLET, FILM COATED [MELALEUCA, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CALMICID AC ACID REDUCER (LORATADINE) TABLET, FILM COATED [MELALEUCA, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4CALMICID AC ACID REDUCER (LORATADINE) TABLET, FILM COATED [MELALEUCA, INC.]2
TalcINACTIVE INGREDIENT7SEV7J4R1UCALMICID AC ACID REDUCER (LORATADINE) TABLET, FILM COATED [MELALEUCA, INC.]2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPCALMICID AC ACID REDUCER (LORATADINE) TABLET, FILM COATED [MELALEUCA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-203CALMICID AC ACID REDUCER (LORATADINE) TABLET, FILM COATED [MELALEUCA, INC.]7Legacy NDC, 2 package rows20230106_9aed4009-307c-44ef-8dce-394a8d4c6597.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091399Calmicid AC 20 MG Oral TabletPSN9aed4009-307c-44ef-8dce-394a8d4c65977
310273famotidine 20 MG Oral TabletPSN9aed4009-307c-44ef-8dce-394a8d4c65977
1091399famotidine 20 MG Oral Tablet [Calmicid]SBD9aed4009-307c-44ef-8dce-394a8d4c65977
310273famotidine 20 MG Oral TabletSCD9aed4009-307c-44ef-8dce-394a8d4c65977
1091399Calmicid 20 MG Oral TabletSY9aed4009-307c-44ef-8dce-394a8d4c65977
1091399Calmicid AC 20 MG Oral TabletSY9aed4009-307c-44ef-8dce-394a8d4c65977

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-203-015447302030150 in 1 BOTTLEHistorical
54473-203-50544730203501 BOTTLE in 1 BOX (54473-203-50) > 50 TABLET, FILM COATED in 1 BOTTLE (54473-203-01) 1 bottle2018-01-010000-00-00NoNoCurrent