Chloroquine Phosphate

Product NDC
68022-0265
11-digit product format
680220265
Labeler code
68022
Product ID
68022-0265_db5c9c4e-ed5b-182b-e053-2995a90ab8cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chloroquine Phosphate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Suven Pharmaceuticals Limited
Application
ANDA214756
Marketing category
ANDA
Marketing start
2022-03-01
Marketing end
0000-00-00
Substance
CHLOROQUINE PHOSPHATE
Active strength
500 mg/1
Pharmacologic classes
Antimalarial [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
A214756-001CHLOROQUINE PHOSPHATECHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214756-001AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-034b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-03782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-03cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214756-001CHLOROQUINE PHOSPHATE500MGTABLET / ORALAA2021-09-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A214756-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214756-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214756-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214756-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214756-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214756-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214756-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214756-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214756-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214756-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214756-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214756-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214756-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214756-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214756-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214756-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214756-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214756-001AA14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214756-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214756-001AA1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214756-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214756-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214756-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214756-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214756-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214756-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214756-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A214756-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A214756-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214756-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214756-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214756-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214756-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214756-001AA1a50c72e98297…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68022-0265CHLOROQUINE PHOSPHATE TABLET, COATED [SUVEN PHARMACEUTICALS LIMITED]8Legacy NDC20241224_cc0cb812-48f9-a138-e053-2a95a90a7666.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHLOROQUINE PHOSPHATECHLOROQUINE PHOSPHATEChartwell RX, LLCff199f31-bfda-45f8-adbd-4662f7054f1c2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214756
application number: ANDA214756
Chloroquine PhosphateCHLOROQUINE PHOSPHATEAvet Pharmaceuticals Inc.f4ac1556-0522-76e3-e053-2a95a90a5ba82025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214756
application number: ANDA214756

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68022-0265-168022026501500 TABLET, COATED in 1 BOTTLE, PLASTIC (68022-0265-1) 2021-11-010000-00-00NoNoCurrent