Droxidopa

Product NDC: 69539-088
11-digit product format: 695390088
Labeler code: 69539
Product ID: 69539-088_700c0bc6-b089-4478-8e62-4232cad2348e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Droxidopa
Dosage form: CAPSULE
Route: ORAL
Labeler: MSN LABORATORIES PRIVATE LIMITED
Application: ANDA211741
Marketing category: ANDA
Marketing start: 2021-02-19
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69539-088		D	Discontinued by firm	2026-08-17
excluded package	package	69539-088	69539-088-05	D	Discontinued by firm	2026-08-17
excluded package	package	69539-088	69539-088-90	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	69539-088		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69539-088	69539-088-05	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69539-088	69539-088-90	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	Approval date
A211741-001	DROXIDOPA	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18
A211741-002	DROXIDOPA	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18
A211741-003	DROXIDOPA	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A211741-001	AB
A211741-002	AB
A211741-003	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 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A211741-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211741-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211741-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211741-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211741-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211741-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211741-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211741-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211741-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211741-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211741-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211741-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211741-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211741-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211741-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211741-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211741-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211741-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211741-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211741-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211741-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211741-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211741-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211741-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211741-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211741-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211741-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211741-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211741-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211741-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211741-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211741-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211741-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211741-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211741-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211741-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211741-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211741-002	DROXIDOPA	200MG	CAPSULE / ORAL	AB	2021-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211741-003	DROXIDOPA	300MG	CAPSULE / ORAL	AB	2021-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211741-001	DROXIDOPA	100MG	CAPSULE / ORAL	AB	2021-02-18	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211741-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211741-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211741-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211741-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211741-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211741-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211741-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211741-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211741-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211741-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211741-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211741-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211741-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211741-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211741-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211741-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211741-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211741-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211741-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211741-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211741-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211741-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211741-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211741-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211741-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211741-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211741-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211741-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211741-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211741-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211741-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211741-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211741-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211741-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211741-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211741-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211741-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211741-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211741-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211741-001	AB	1	`1e350fbaab3a…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69539-088	DROXIDOPA CAPSULE [MSN LABORATORIES PRIVATE LIMITED]	1	Legacy NDC	20210222_700c0bc6-b089-4478-8e62-4232cad2348e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Droxidopa	DROXIDOPA	Novadoz Pharmaceuticals LLC	381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211741 application number: ANDA211741
Droxidopa	DROXIDOPA	MAJOR PHARMACEUTICALS	04b1f69d-ebba-43b9-8ecd-4f6be7c8a0a0	2024-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211741 application number: ANDA211741

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J7A92W69L7	DROXIDOPA	23651-95-8	DROXIDOPA

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69539-088-05	69539008805	500 CAPSULE in 1 BOTTLE (69539-088-05)	500 capsule	2021-02-19	0000-00-00	No	No	Current
69539-088-90	69539008890	90 CAPSULE in 1 BOTTLE (69539-088-90)	90 capsule	2021-02-19	0000-00-00	No	No	Current