Home NDC 55289-856 Chloroquine
Product NDC 55289-856
11-digit product format 552890856
Labeler code 55289
Product ID 55289-856_7bbd2559-4abd-9f18-e053-2991aa0a152e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chloroquine Phosphate
Dosage form TABLET, COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
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 No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A083082-001 CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 A083082-002 CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1999-09-17
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A083082-001 CHLOROQUINE PHOSPHATE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A083082-002 CHLOROQUINE PHOSPHATE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1999-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083082-001 CHLOROQUINE PHOSPHATE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A083082-002 CHLOROQUINE PHOSPHATE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1999-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A083082-001 CHLOROQUINE PHOSPHATE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A083082-002 CHLOROQUINE PHOSPHATE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1999-09-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A083082-001 CHLOROQUINE PHOSPHATE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A083082-002 CHLOROQUINE PHOSPHATE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1999-09-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A083082-001 CHLOROQUINE PHOSPHATE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A083082-002 CHLOROQUINE PHOSPHATE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1999-09-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A083082-001 CHLOROQUINE PHOSPHATE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A083082-002 CHLOROQUINE PHOSPHATE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1999-09-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A083082-001 CHLOROQUINE PHOSPHATE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A083082-002 CHLOROQUINE PHOSPHATE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1999-09-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A083082-001 CHLOROQUINE PHOSPHATE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A083082-002 CHLOROQUINE PHOSPHATE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1999-09-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A083082-001 CHLOROQUINE PHOSPHATE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A083082-002 CHLOROQUINE PHOSPHATE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1999-09-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A083082-001 CHLOROQUINE PHOSPHATE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A083082-002 CHLOROQUINE PHOSPHATE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1999-09-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A083082-001 CHLOROQUINE PHOSPHATE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A083082-002 CHLOROQUINE PHOSPHATE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1999-09-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A083082-001 CHLOROQUINE PHOSPHATE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A083082-002 CHLOROQUINE PHOSPHATE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1999-09-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A083082-001 CHLOROQUINE PHOSPHATE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A083082-002 CHLOROQUINE PHOSPHATE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1999-09-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A083082-001 CHLOROQUINE PHOSPHATE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A083082-002 CHLOROQUINE PHOSPHATE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL 1999-09-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A083082-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A083082-002 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL 1999-09-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A083082-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A083082-002 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL 1999-09-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A083082-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A083082-002 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL 1999-09-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A083082-001 CHLOROQUINE PHOSPHATE EQ 150MG BASE TABLET / ORAL AA RS, Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A083082-002 CHLOROQUINE PHOSPHATE EQ 300MG BASE TABLET / ORAL AA 1999-09-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A083082-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A083082-002 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL 1999-09-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A083082-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A083082-002 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL 1999-09-17 782e0a99824c…
Observed Orange Book normalized TE history#