Home NDC 63304-104 droxidopa
Product NDC 63304-104
11-digit product format 633040104
Labeler code 63304
Product ID 63304-104_ca97f06d-5449-4f4f-a362-47f65448bf8c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name droxidopa
Dosage form CAPSULE
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA214384
Marketing category ANDA
Marketing start 2021-02-18
Substance DROXIDOPA
Active strength 200 ug/1
Pharmacologic classes Catecholamines [CS], Increased Blood Pressure [PE]
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214384-001 DROXIDOPA DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 A214384-002 DROXIDOPA DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 A214384-003 DROXIDOPA DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 3 · 102 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 A214384-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214384-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214384-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214384-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214384-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214384-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214384-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214384-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214384-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214384-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214384-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214384-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214384-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214384-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214384-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214384-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214384-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214384-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214384-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214384-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214384-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214384-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214384-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214384-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214384-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214384-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214384-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214384-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214384-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214384-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214384-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214384-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214384-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214384-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214384-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214384-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214384-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214384-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214384-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214384-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 102 observed states.
Additional Listing Data#
Finished product Yes
Brand name base droxidopa
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DROXIDOPA 200 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J7A92W69L7 Internal UNII 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 63304-104-90 droxidopa 90 in 1 BOTTLE CAPSULE 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63304-104 DROXIDOPA CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20210223_51ef3096-4622-4f45-a180-ab0dc6d46df9.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 droxidopa DROXIDOPA Sun Pharmaceutical Industries, Inc. 51ef3096-4622-4f45-a180-ab0dc6d46df9 2021-02-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 214384 application number: ANDA214384 ndc (product): 63304-104
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63304-104-90 63304010490 90 CAPSULE in 1 BOTTLE (63304-104-90) 90 capsule 2021-02-18 0000-00-00 No No Current