Chloroquine Phosphate

Product NDC
64980-178
11-digit product format
649800178
Labeler code
64980
Product ID
64980-178_6d4407d6-9669-4bf6-91cf-05ec2d70c96a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chloroquine Phosphate
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA090612
Marketing category
ANDA
Marketing start
2011-07-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090612-001CHLOROQUINE PHOSPHATECHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A090612-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090612-001CHLOROQUINE PHOSPHATEEQ 300MG BASETABLET / ORALAARS2011-01-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090612-001CHLOROQUINE PHOSPHATEEQ 300MG BASETABLET / ORALAARS2011-01-213f01610625f2…
2019-09-15 20:21 UTC2019-09A090612-001CHLOROQUINE PHOSPHATEEQ 300MG BASETABLET / ORALAARS2011-01-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A090612-001CHLOROQUINE PHOSPHATEEQ 300MG BASETABLET / ORALAARS2011-01-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090612-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAARS2011-01-21e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090612-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090612-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090612-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090612-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090612-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090612-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090612-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090612-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090612-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090612-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090612-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090612-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090612-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090612-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090612-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090612-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090612-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090612-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090612-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090612-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090612-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090612-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A090612-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090612-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090612-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090612-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A090612-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090612-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090612-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090612-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090612-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090612-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090612-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090612-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090612-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090612-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090612-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090612-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090612-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090612-001AA1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Chloroquine Phosphate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROQUINE PHOSPHATE500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6E17K3343PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1116758Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06c69e2b-211b-4746-9f3a-f86d36520570Available on FDA.report

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
64980-178-01Chloroquine Phosphate100 in 1 BOTTLE, PLASTICTABLET1006
64980-178-02Chloroquine Phosphate25 in 1 BOTTLE, PLASTICTABLET256
64980-178-05Chloroquine Phosphate500 in 1 BOTTLE, PLASTICTABLET5006
64980-178-10Chloroquine Phosphate1000 in 1 BOTTLE, PLASTICTABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-178-02EA - Each64980-178371227f7-b524-48f1-acf5-ddbe8220d87312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLOROQUINE PHOSPHATEACTIVE INGREDIENT6E17K3343PCHLOROQUINE PHOSPHATE TABLET [RISING PHARMACEUTICALS, INC.]1
CHLOROQUINEACTIVE MOIETY886U3H6UFFCHLOROQUINE PHOSPHATE TABLET [RISING PHARMACEUTICALS, INC.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JCHLOROQUINE PHOSPHATE TABLET [RISING PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLOROQUINE PHOSPHATE TABLET [RISING PHARMACEUTICALS, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CHLOROQUINE PHOSPHATE TABLET [RISING PHARMACEUTICALS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCHLOROQUINE PHOSPHATE TABLET [RISING PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHLOROQUINE PHOSPHATE TABLET [RISING PHARMACEUTICALS, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACHLOROQUINE PHOSPHATE TABLET [RISING PHARMACEUTICALS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCHLOROQUINE PHOSPHATE TABLET [RISING PHARMACEUTICALS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CHLOROQUINE PHOSPHATE TABLET [RISING PHARMACEUTICALS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCHLOROQUINE PHOSPHATE TABLET [RISING PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCHLOROQUINE PHOSPHATE TABLET [RISING PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-178CHLOROQUINE PHOSPHATE TABLET [RISING PHARMA HOLDINGS, INC.]6Current NDC, Legacy NDC, 4 package rows20241027_06c69e2b-211b-4746-9f3a-f86d36520570.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chloroquine PhosphateCHLOROQUINE PHOSPHATERising Pharma Holdings, Inc.06c69e2b-211b-4746-9f3a-f86d365205702026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090612
application number: ANDA090612
ndc (product): 64980-178

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116758chloroquine phosphate 500 MG Oral TabletPSN06c69e2b-211b-4746-9f3a-f86d365205706
1116758chloroquine phosphate 500 MG Oral TabletSCD06c69e2b-211b-4746-9f3a-f86d365205706
1116758chloroquine phosphate 500 MG (chloroquine 300 MG) Oral TabletSY06c69e2b-211b-4746-9f3a-f86d365205706

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-178-0164980017801100 TABLET in 1 BOTTLE, PLASTIC (64980-178-01) 100 tablet2011-07-010000-00-00NoNoCurrent
64980-178-026498001780225 TABLET in 1 BOTTLE, PLASTIC (64980-178-02) 25 tablet2011-07-010000-00-00NoNoCurrent
64980-178-0564980017805500 TABLET in 1 BOTTLE, PLASTIC (64980-178-05) 500 tablet2011-07-010000-00-00NoNoCurrent
64980-178-10649800178101000 TABLET in 1 BOTTLE, PLASTIC (64980-178-10) 1000 tablet2011-07-010000-00-00NoNoCurrent