Home NDC 65162-811 Quinine Sulfate
Product NDC 65162-811
11-digit product format 651620811
Labeler code 65162
Product ID 65162-811_b1b6d20f-5e99-4205-9f40-fa4a8af3416d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Quinine
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA203729
Marketing category ANDA
Marketing start 2016-07-29
Substance QUININE SULFATE
Active strength 324 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 1 .
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 A203729-001 QUININE SULFATE QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203729-001 AB
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 · 41 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 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203729-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-07-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Quinine Sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength QUININE SULFATE 324 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KF7Z0E0Q2B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 997010 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 65162-811-03 Quinine Sulfate 30 in 1 BOTTLE CAPSULE 30 11 65162-811-09 Quinine Sulfate 90 in 1 BOTTLE CAPSULE 90 11 65162-811-50 Quinine Sulfate 500 in 1 BOTTLE CAPSULE 500 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-811 QUININE SULFATE (QUININE) CAPSULE [AMNEAL PHARMACEUTICALS LLC] 11 Current NDC, Legacy NDC, 3 package rows 20241210_f567d5c7-ea5d-49a7-a035-b47208135f73.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 65162-811-03 65162081103 30 CAPSULE in 1 BOTTLE (65162-811-03) 30 capsule 2016-07-29 0000-00-00 No No Current 65162-811-09 65162081109 90 CAPSULE in 1 BOTTLE (65162-811-09) 90 capsule 2016-07-29 0000-00-00 No No Current 65162-811-50 65162081150 500 CAPSULE in 1 BOTTLE (65162-811-50) 500 capsule 2016-07-29 0000-00-00 No No Current