FDA.reportPublic FDA data

Chloroquine Phosphate

Product NDC
0115-7010
11-digit product format
001157010
Labeler code
0115
Product ID
0115-7010_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
ANDA040516
Marketing category
ANDA
Marketing start
2022-05-10
Substance
CHLOROQUINE PHOSPHATE
Active strength
500 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 PHOSPHATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6E17K3343P
Rxcui1116758, 1117531

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a9f7e454-734f-4d97-ba4f-246ab0e6c36dProduct name220220311
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-7010-01Chloroquine Phosphate100 in 1 BOTTLETABLET10011
0115-7010-02Chloroquine Phosphate500 in 1 BOTTLETABLET50011
0115-7010-09Chloroquine Phosphate25 in 1 BOTTLETABLET2511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-7010-09EA - Each0115-701014804f58-cd04-4a23-8ffd-6fa22e3949a012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLOROQUINE PHOSPHATEACTIVE INGREDIENT6E17K3343PCHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
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
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
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, 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
0115-7010CHLOROQUINE PHOSPHATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]6Current NDC, Legacy NDC, 3 package rows20231231_eb02c52d-907c-43fb-aa8f-2f378a9087e7.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
1116758chloroquine phosphate 500 MG Oral TabletPSN0a342f72-45f9-3e12-e063-6394a90ae33e2
1116758chloroquine phosphate 500 MG Oral TabletSCD0a342f72-45f9-3e12-e063-6394a90ae33e2
1116758chloroquine phosphate 500 MG (chloroquine 300 MG) Oral TabletSY0a342f72-45f9-3e12-e063-6394a90ae33e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-7010-0100115701001100 TABLET in 1 BOTTLE (0115-7010-01) 100 tablet2022-05-100000-00-00NoNoCurrent
0115-7010-0200115701002500 TABLET in 1 BOTTLE (0115-7010-02) 500 tablet2022-05-100000-00-00NoNoCurrent
0115-7010-090011570100925 TABLET in 1 BOTTLE (0115-7010-09) 25 tablet2022-05-100000-00-00NoNoCurrent