FDA.reportPublic FDA data

Chloroquine Phosphate

Product NDC
0115-2790
11-digit product format
001152790
Labeler code
0115
Product ID
0115-2790_129278f0-8928-4330-899a-b1602818700d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLOROQUINE PHOSPHATE
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA080880
Marketing category
ANDA
Marketing start
2022-05-10
Substance
CHLOROQUINE PHOSPHATE
Active strength
250 mg/1
Pharmacologic classes
Antimalarial [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Chloroquine Phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROQUINE PHOSPHATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E17K3343P
Rxcui1116758, 1117531

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a9f7e454-734f-4d97-ba4f-246ab0e6c36dProduct name220220311

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-2790-02Chloroquine Phosphate500 in 1 BOTTLETABLET50011
0115-2790-06Chloroquine Phosphate50 in 1 BOTTLETABLET5011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-2790-06EA - Each0115-2790588c7e13-a40b-43fc-9ebd-682ee87a93ea12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLOROQUINE PHOSPHATEACTIVE INGREDIENT6E17K3343PCHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
CHLOROQUINE PHOSPHATEACTIVE INGREDIENT6E17K3343PCHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
CHLOROQUINEACTIVE MOIETY886U3H6UFFCHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
CHLOROQUINEACTIVE MOIETY886U3H6UFFCHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TCHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TCHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-2790CHLOROQUINE PHOSPHATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]6Current NDC, Legacy NDC20230915_638e62df-5bbc-41c3-aa88-eb36781c2af6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1117531chloroquine phosphate 250 MG Oral TabletPSNeb02c52d-907c-43fb-aa8f-2f378a9087e711
1116758chloroquine phosphate 500 MG Oral TabletPSNeb02c52d-907c-43fb-aa8f-2f378a9087e711
1117531chloroquine phosphate 250 MG Oral TabletSCDeb02c52d-907c-43fb-aa8f-2f378a9087e711
1116758chloroquine phosphate 500 MG Oral TabletSCDeb02c52d-907c-43fb-aa8f-2f378a9087e711
1117531chloroquine phosphate 250 MG (eqv to chloroquine 150 MG) Oral TabletSYeb02c52d-907c-43fb-aa8f-2f378a9087e711
1116758chloroquine phosphate 500 MG (chloroquine 300 MG) Oral TabletSYeb02c52d-907c-43fb-aa8f-2f378a9087e711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-2790-0200115279002500 TABLET in 1 BOTTLE (0115-2790-02) 500 tablet2022-05-100000-00-00NoNoCurrent
0115-2790-060011527900650 TABLET in 1 BOTTLE (0115-2790-06) 50 tablet2022-05-100000-00-00NoNoCurrent