Home NDC 68180-560 QUININE SULFATE
Product NDC 68180-560
11-digit product format 681800560
Labeler code 68180
Product ID 68180-560_8cd4d427-50ac-4f9c-a029-e7c2d063679a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name QUININE SULFATE
Dosage form CAPSULE
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA203112
Marketing category ANDA
Marketing start 2015-08-04
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 A203112-001 QUININE SULFATE QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203112-001 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 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203112-001 QUININE SULFATE 324MG CAPSULE / ORAL AB 2015-04-24 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 68180-560-01 QUININE SULFATE 100 in 1 BOTTLE CAPSULE 100 14 68180-560-02 QUININE SULFATE 500 in 1 BOTTLE CAPSULE 500 14 68180-560-03 QUININE SULFATE 1000 in 1 BOTTLE CAPSULE 1000 14 68180-560-06 QUININE SULFATE 30 in 1 BOTTLE CAPSULE 30 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded QUININE SULFATE ACTIVE INGREDIENT KF7Z0E0Q2B QUININE SULFATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 4 QUININE ACTIVE MOIETY A7V27PHC7A QUININE SULFATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 4 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 QUININE SULFATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 4 GELATIN INACTIVE INGREDIENT 2G86QN327L QUININE SULFATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 QUININE SULFATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 4 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T QUININE SULFATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 QUININE SULFATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 4 SHELLAC INACTIVE INGREDIENT 46N107B71O QUININE SULFATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J QUININE SULFATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ QUININE SULFATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U QUININE SULFATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-560 QUININE SULFATE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 11 Current NDC, Legacy NDC, 4 package rows 20231102_1f32f05c-a215-40be-b951-e41a7b54a8a0.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 68180-560-01 68180056001 100 CAPSULE in 1 BOTTLE (68180-560-01) 100 capsule 2015-08-04 0000-00-00 No No Current 68180-560-02 68180056002 500 CAPSULE in 1 BOTTLE (68180-560-02) 500 capsule 2015-08-04 0000-00-00 No No Current 68180-560-03 68180056003 1000 CAPSULE in 1 BOTTLE (68180-560-03) 1000 capsule 2015-08-04 0000-00-00 No No Current 68180-560-06 68180056006 30 CAPSULE in 1 BOTTLE (68180-560-06) 30 capsule 2015-08-04 0000-00-00 No No Current