Chloroquine

Product NDC
68151-0487
11-digit product format
681510487
Labeler code
68151
Product ID
68151-0487_63079f04-872d-412d-b030-244594867225
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chloroquine Phosphate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA083082
Marketing category
ANDA
Marketing start
1999-09-17
Marketing end
0000-00-00
Substance
CHLOROQUINE PHOSPHATE
Active strength
500 mg/1
Pharmacologic classes
Antimalarial [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68151-0487IInactivated by FDA2026-08-07
excluded packagepackage68151-048768151-0487-2IInactivated by FDA2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68151-0487-2IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68151-0487-2IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68151-0487-2IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68151-0487-2IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68151-0487-2IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68151-0487-2IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68151-0487-2IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68151-0487-2IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68151-0487-2IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68151-0487-2IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68151-0487-2IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68151-0487-2IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68151-0487-2IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68151-0487-2IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68151-0487-2IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68151-0487-2IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68151-0487-2IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68151-0487-2IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68151-0487-2IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68151-0487-2IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68151-0487-2IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68151-0487-2EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A083082-001CHLOROQUINE PHOSPHATECHLOROQUINE PHOSPHATE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982
A083082-002CHLOROQUINE PHOSPHATECHLOROQUINE PHOSPHATE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1999-09-17

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A083082-001CHLOROQUINE PHOSPHATE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083082-002CHLOROQUINE PHOSPHATE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1999-09-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083082-001CHLOROQUINE PHOSPHATE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083082-002CHLOROQUINE PHOSPHATE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1999-09-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A083082-001CHLOROQUINE PHOSPHATE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A083082-002CHLOROQUINE PHOSPHATE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1999-09-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083082-001CHLOROQUINE PHOSPHATE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083082-002CHLOROQUINE PHOSPHATE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1999-09-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083082-001CHLOROQUINE PHOSPHATE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083082-002CHLOROQUINE PHOSPHATE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1999-09-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083082-001CHLOROQUINE PHOSPHATE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083082-002CHLOROQUINE PHOSPHATE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1999-09-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083082-001CHLOROQUINE PHOSPHATE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083082-002CHLOROQUINE PHOSPHATE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1999-09-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083082-001CHLOROQUINE PHOSPHATE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083082-002CHLOROQUINE PHOSPHATE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1999-09-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083082-001CHLOROQUINE PHOSPHATE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083082-002CHLOROQUINE PHOSPHATE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1999-09-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A083082-001CHLOROQUINE PHOSPHATE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A083082-002CHLOROQUINE PHOSPHATE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1999-09-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A083082-001CHLOROQUINE PHOSPHATE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A083082-002CHLOROQUINE PHOSPHATE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1999-09-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A083082-001CHLOROQUINE PHOSPHATE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A083082-002CHLOROQUINE PHOSPHATE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1999-09-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A083082-001CHLOROQUINE PHOSPHATE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A083082-002CHLOROQUINE PHOSPHATE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1999-09-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A083082-001CHLOROQUINE PHOSPHATE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A083082-002CHLOROQUINE PHOSPHATE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1999-09-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A083082-001CHLOROQUINE PHOSPHATE250MGTABLET / ORALApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A083082-002CHLOROQUINE PHOSPHATE500MGTABLET / ORAL1999-09-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A083082-001CHLOROQUINE PHOSPHATE250MGTABLET / ORALApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A083082-002CHLOROQUINE PHOSPHATE500MGTABLET / ORAL1999-09-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A083082-001CHLOROQUINE PHOSPHATE250MGTABLET / ORALApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A083082-002CHLOROQUINE PHOSPHATE500MGTABLET / ORAL1999-09-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A083082-001CHLOROQUINE PHOSPHATEEQ 150MG BASETABLET / ORALAARS, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A083082-002CHLOROQUINE PHOSPHATEEQ 300MG BASETABLET / ORALAA1999-09-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A083082-001CHLOROQUINE PHOSPHATE250MGTABLET / ORALApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A083082-002CHLOROQUINE PHOSPHATE500MGTABLET / ORAL1999-09-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A083082-001CHLOROQUINE PHOSPHATE250MGTABLET / ORALApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12A083082-002CHLOROQUINE PHOSPHATE500MGTABLET / ORAL1999-09-17782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A083082-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A083082-002AA174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A083082-001AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A083082-002AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A083082-001AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A083082-002AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A083082-001AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A083082-002AA1ea99ee380514…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-0487-22020-01-31C16284748780-19d75b9d0-0694-f424-e053-dadaa90a57ceCHLOROQUINE PHOSPHATE TABLETS, USP 250 MG and 500 MG

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLOROQUINE PHOSPHATEACTIVE INGREDIENT6E17K3343PCHLOROQUINE (CHLOROQUINE PHOSPHATE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
CHLOROQUINEACTIVE MOIETY886U3H6UFFCHLOROQUINE (CHLOROQUINE PHOSPHATE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLOROQUINE (CHLOROQUINE PHOSPHATE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KCHLOROQUINE (CHLOROQUINE PHOSPHATE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLOROQUINE (CHLOROQUINE PHOSPHATE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLOROQUINE (CHLOROQUINE PHOSPHATE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCHLOROQUINE (CHLOROQUINE PHOSPHATE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCHLOROQUINE (CHLOROQUINE PHOSPHATE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHLOROQUINE (CHLOROQUINE PHOSPHATE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACHLOROQUINE (CHLOROQUINE PHOSPHATE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCHLOROQUINE (CHLOROQUINE PHOSPHATE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCHLOROQUINE (CHLOROQUINE PHOSPHATE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CHLOROQUINE (CHLOROQUINE PHOSPHATE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CHLOROQUINE (CHLOROQUINE PHOSPHATE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCHLOROQUINE (CHLOROQUINE PHOSPHATE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCHLOROQUINE (CHLOROQUINE PHOSPHATE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2