Home NDC 0115-7010 Chloroquine Phosphate
Product NDC 0115-7010
11-digit product format 001157010
Labeler code 0115
Product ID 0115-7010_129278f0-8928-4330-899a-b1602818700d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CHLOROQUINE PHOSPHATE
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA040516
Marketing category ANDA
Marketing start 2022-05-10
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040516-001 CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040516-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL 2003-08-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL 2003-08-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL 2003-08-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040516-001 CHLOROQUINE PHOSPHATE EQ 300MG BASE TABLET / ORAL 2003-08-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL 2003-08-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL 2003-08-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL 2003-08-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL 2003-08-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL 2003-08-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL 2003-08-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040516-001 CHLOROQUINE PHOSPHATE EQ 300MG BASE TABLET / ORAL 2003-08-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040516-001 CHLOROQUINE PHOSPHATE EQ 300MG BASE TABLET / ORAL 2003-08-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040516-001 CHLOROQUINE PHOSPHATE EQ 300MG BASE TABLET / ORAL 2003-08-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL AA 2003-08-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL 2003-08-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040516-001 CHLOROQUINE PHOSPHATE 500MG TABLET / ORAL 2003-08-29 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Chloroquine Phosphate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLOROQUINE PHOSPHATE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6E17K3343P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1116758 Internal RxNorm lookup 1117531 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0115-7010-01 Chloroquine Phosphate 100 in 1 BOTTLE TABLET 100 11 0115-7010-02 Chloroquine Phosphate 500 in 1 BOTTLE TABLET 500 11 0115-7010-09 Chloroquine Phosphate 25 in 1 BOTTLE TABLET 25 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 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 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 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, 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 0115-7010 CHLOROQUINE PHOSPHATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 6 Current NDC, Legacy NDC, 3 package rows 20231231_eb02c52d-907c-43fb-aa8f-2f378a9087e7.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.
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 0115-7010-01 00115701001 100 TABLET in 1 BOTTLE (0115-7010-01) 100 tablet 2022-05-10 0000-00-00 No No Current 0115-7010-02 00115701002 500 TABLET in 1 BOTTLE (0115-7010-02) 500 tablet 2022-05-10 0000-00-00 No No Current 0115-7010-09 00115701009 25 TABLET in 1 BOTTLE (0115-7010-09) 25 tablet 2022-05-10 0000-00-00 No No Current