Home NDC 27241-200 Droxidopa
Product NDC 27241-200
11-digit product format 272410200
Labeler code 27241
Product ID 27241-200_b1f03a9d-03b5-4402-bfb6-fb7055e896a6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Droxidopa
Dosage form CAPSULE
Route ORAL
Labeler Ajanta Pharma USA Inc.
Application ANDA214391
Marketing category ANDA
Marketing start 2021-02-18
Marketing end 0000-00-00
Substance DROXIDOPA
Active strength 200 mg/1
Pharmacologic classes Catecholamines [CS],Increased Blood Pressure [PE]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 A214391-001 DROXIDOPA DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 A214391-002 DROXIDOPA DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 A214391-003 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 A214391-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214391-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214391-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214391-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214391-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214391-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214391-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214391-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214391-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214391-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214391-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214391-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214391-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214391-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214391-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214391-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214391-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214391-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214391-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214391-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214391-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214391-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214391-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214391-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214391-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214391-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214391-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214391-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214391-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214391-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214391-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214391-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214391-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214391-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214391-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214391-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214391-001 DROXIDOPA 100MG CAPSULE / ORAL AB 2021-02-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214391-002 DROXIDOPA 200MG CAPSULE / ORAL AB 2021-02-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214391-003 DROXIDOPA 300MG CAPSULE / ORAL AB 2021-02-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214391-001 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 27241-200-90 Droxidopa 90 in 1 BOTTLE CAPSULE 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27241-200 DROXIDOPA CAPSULE [AJANTA PHARMA USA INC.] 2 Legacy NDC, 1 package rows 20211124_1cefef7e-51b3-494c-946d-d5ae92bdc66a.zip
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 27241-200-90 27241020090 90 CAPSULE in 1 BOTTLE (27241-200-90) 90 capsule 2021-02-18 0000-00-00 No No Current