Home NDC 0115-2790 Chloroquine Phosphate
Product NDC 0115-2790
11-digit product format 001152790
Labeler code 0115
Product ID 0115-2790_56743cf7-5892-48a1-bf23-7479b8ebbc23
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CHLOROQUINE PHOSPHATE
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA080880
Marketing category ANDA
Marketing start 2022-05-10
Substance CHLOROQUINE PHOSPHATE
Active strength 250 mg/1
Pharmacologic classes Antimalarial [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A080880-001 CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A080880-001 AA
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 · 43 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 2026-09-14 22:38:34 2026-08 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A080880-001 CHLOROQUINE PHOSPHATE EQ 150MG BASE TABLET / ORAL Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A080880-001 CHLOROQUINE PHOSPHATE EQ 150MG BASE TABLET / ORAL Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A080880-001 CHLOROQUINE PHOSPHATE EQ 150MG BASE TABLET / ORAL Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A080880-001 CHLOROQUINE PHOSPHATE EQ 150MG BASE TABLET / ORAL Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL AA Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A080880-001 CHLOROQUINE PHOSPHATE 250MG TABLET / ORAL Approved before 1982 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Chloroquine Phosphate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLOROQUINE PHOSPHATE 250 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0115-2790-02 Chloroquine Phosphate 500 in 1 BOTTLE TABLET 500 11 0115-2790-06 Chloroquine Phosphate 50 in 1 BOTTLE TABLET 50 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHLOROQUINE PHOSPHATE ACTIVE INGREDIENT 6E17K3343P CHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 CHLOROQUINE PHOSPHATE ACTIVE INGREDIENT 6E17K3343P CHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 CHLOROQUINE ACTIVE MOIETY 886U3H6UFF CHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 CHLOROQUINE ACTIVE MOIETY 886U3H6UFF CHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 STARCH, POTATO INACTIVE INGREDIENT 8I089SAH3T CHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2 STARCH, POTATO INACTIVE INGREDIENT 8I089SAH3T CHLOROQUINE PHOSPHATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-2790 CHLOROQUINE PHOSPHATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 6 Current NDC, Legacy NDC 20230915_638e62df-5bbc-41c3-aa88-eb36781c2af6.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0115-2790-02 00115279002 500 TABLET in 1 BOTTLE (0115-2790-02) 500 tablet 2022-05-10 0000-00-00 No No Current 0115-2790-06 00115279006 50 TABLET in 1 BOTTLE (0115-2790-06) 50 tablet 2022-05-10 0000-00-00 No No Current