Home NDC 70954-804 SOVUNA
Product NDC 70954-804
11-digit product format 709540804
Labeler code 70954
Product ID 70954-804_f8c163b7-15a0-424d-b53d-05fb400948bf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroxychloroquine Sulfate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application NDA214581
Marketing category NDA
Marketing start 2023-09-15
Substance HYDROXYCHLOROQUINE SULFATE
Active strength 200 mg/1
Pharmacologic classes Antimalarial [EPC], Antirheumatic Agent [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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214581-001 SOVUNA HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL RLD 2022-01-14 N214581-002 SOVUNA HYDROXYCHLOROQUINE SULFATE 300MG TABLET / ORAL RLD, RS 2022-01-14
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 · 64 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 N214581-001 SOVUNA 200MG TABLET / ORAL RLD 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214581-002 SOVUNA 300MG TABLET / ORAL RLD, RS 2022-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214581-001 SOVUNA 200MG TABLET / ORAL RLD 2022-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214581-002 SOVUNA 300MG TABLET / ORAL RLD, RS 2022-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214581-001 SOVUNA 200MG TABLET / ORAL RLD 2022-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214581-002 SOVUNA 300MG TABLET / ORAL RLD, RS 2022-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214581-001 SOVUNA 200MG TABLET / ORAL RLD 2022-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214581-002 SOVUNA 300MG TABLET / ORAL RLD, RS 2022-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214581-001 SOVUNA 200MG TABLET / ORAL RLD 2022-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214581-002 SOVUNA 300MG TABLET / ORAL RLD, RS 2022-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214581-001 SOVUNA 200MG TABLET / ORAL RLD 2022-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214581-002 SOVUNA 300MG TABLET / ORAL RLD, RS 2022-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214581-001 SOVUNA 200MG TABLET / ORAL RLD 2022-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214581-002 SOVUNA 300MG TABLET / ORAL RLD, RS 2022-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214581-001 SOVUNA 200MG TABLET / ORAL RLD 2022-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214581-002 SOVUNA 300MG TABLET / ORAL RLD, RS 2022-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214581-001 SOVUNA 200MG TABLET / ORAL RLD 2022-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214581-002 SOVUNA 300MG TABLET / ORAL RLD, RS 2022-01-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214581-001 SOVUNA 200MG TABLET / ORAL RLD 2022-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214581-002 SOVUNA 300MG TABLET / ORAL RLD, RS 2022-01-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214581-001 SOVUNA 200MG TABLET / ORAL RLD 2022-01-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214581-002 SOVUNA 300MG TABLET / ORAL RLD, RS 2022-01-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214581-001 SOVUNA 200MG TABLET / ORAL RLD 2022-01-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214581-002 SOVUNA 300MG TABLET / ORAL RLD, RS 2022-01-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214581-001 SOVUNA 200MG TABLET / ORAL RLD 2022-01-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214581-002 SOVUNA 300MG TABLET / ORAL RLD, RS 2022-01-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214581-001 SOVUNA 200MG TABLET / ORAL RLD 2022-01-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N214581-002 SOVUNA 300MG TABLET / ORAL RLD, RS 2022-01-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214581-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL RLD 2022-01-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214581-002 HYDROXYCHLOROQUINE SULFATE 300MG TABLET / ORAL RLD, RS 2022-01-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214581-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL RLD 2022-01-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N214581-002 HYDROXYCHLOROQUINE SULFATE 300MG TABLET / ORAL RLD, RS 2022-01-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214581-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL RLD 2022-01-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N214581-002 HYDROXYCHLOROQUINE SULFATE 300MG TABLET / ORAL RLD, RS 2022-01-14 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214581-001 HYDROXYCHLOROQUINE SULFATE 200MG TABLET / ORAL RLD 2022-01-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N214581-002 HYDROXYCHLOROQUINE SULFATE 300MG TABLET / ORAL RLD, RS 2022-01-14 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214581-001 SOVUNA 200MG TABLET / ORAL RLD 2022-01-14 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214581-002 SOVUNA 300MG TABLET / ORAL RLD, RS 2022-01-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214581-001 SOVUNA 200MG TABLET / ORAL RLD 2022-01-14 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N214581-002 SOVUNA 300MG TABLET / ORAL RLD, RS 2022-01-14 1c564ffb4f44…
Additional Listing Data#
Finished product Yes
Brand name base SOVUNA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROXYCHLOROQUINE SULFATE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8Q2869CNVH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 979092 Internal RxNorm lookup 2569283 Internal RxNorm lookup 2665282 Internal RxNorm lookup 2665284 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 70954-804-10 SOVUNA 30 in 1 BOTTLE TABLET, FILM COATED 30 4 70954-804-20 SOVUNA 100 in 1 BOTTLE TABLET, FILM COATED 100 4 70954-804-30 SOVUNA 14 in 1 BOTTLE TABLET, FILM COATED 14 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-804 SOVUNA (HYDROXYCHLOROQUINE SULFATE) TABLET, FILM COATED [ANI PHARMACEUTICALS, INC.] 4 Current NDC, 3 package rows 20250131_dd441154-b196-4d4c-bc56-2e37f345ef8d.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SOVUNA HYDROXYCHLOROQUINE SULFATE ANI Pharmaceuticals, Inc. dd441154-b196-4d4c-bc56-2e37f345ef8d 2024-10-08 Warnings, Adverse reactions Exact identifier application applno (NDA): 214581 application number: NDA214581 ndc (product): 70954-804
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70954-804-10 70954080410 30 TABLET, FILM COATED in 1 BOTTLE (70954-804-10) 2023-09-15 No No Current 70954-804-20 70954080420 100 TABLET, FILM COATED in 1 BOTTLE (70954-804-20) 2023-09-15 No No Current 70954-804-30 70954080430 14 TABLET, FILM COATED in 1 BOTTLE (70954-804-30) 2023-09-15 Yes No Current