Northera

Product NDC: 67386-821
11-digit product format: 673860821
Labeler code: 67386
Product ID: 67386-821_5e69b39c-3254-43bc-ae4d-258222a964d5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: droxidopa
Dosage form: CAPSULE
Route: ORAL
Labeler: Lundbeck Pharmaceuticals LLC
Application: NDA203202
Marketing category: NDA
Marketing start: 2014-09-01
Substance: DROXIDOPA
Active strength: 200 mg/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
N203202-001	NORTHERA	DROXIDOPA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18
N203202-002	NORTHERA	DROXIDOPA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18
N203202-003	NORTHERA	DROXIDOPA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N203202-001	AB
N203202-002	AB
N203202-003	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 4 · 123 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	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203202-002	NORTHERA	200MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203202-003	NORTHERA	300MG	CAPSULE / ORAL	AB	RLD, RS	2014-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203202-001	NORTHERA	100MG	CAPSULE / ORAL	AB	RLD	2014-02-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203202-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203202-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203202-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203202-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203202-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203202-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203202-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203202-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203202-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203202-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203202-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203202-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203202-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203202-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203202-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203202-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203202-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203202-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203202-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203202-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203202-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203202-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203202-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203202-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203202-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203202-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203202-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203202-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203202-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203202-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203202-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203202-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203202-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203202-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203202-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203202-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203202-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203202-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203202-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203202-001	AB	1	`8072bd15b7f6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N203202-001	NCE	2019-02-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203202-001	ODE-61	2021-02-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203202-002	NCE	2019-02-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203202-002	ODE-61	2021-02-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203202-003	NCE	2019-02-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203202-003	ODE-61	2021-02-18	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N203202-001	ODE-61	2021-02-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203202-002	ODE-61	2021-02-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203202-003	ODE-61	2021-02-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203202-001	ODE-61	2021-02-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203202-002	ODE-61	2021-02-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203202-003	ODE-61	2021-02-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203202-001	ODE-61	2021-02-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N203202-002	ODE-61	2021-02-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N203202-003	ODE-61	2021-02-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203202-001	ODE-61	2021-02-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203202-002	ODE-61	2021-02-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203202-003	ODE-61	2021-02-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203202-001	ODE-61	2021-02-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203202-002	ODE-61	2021-02-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203202-003	ODE-61	2021-02-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203202-001	NCE	2019-02-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203202-001	ODE-61	2021-02-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203202-002	NCE	2019-02-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203202-002	ODE-61	2021-02-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203202-003	NCE	2019-02-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203202-003	ODE-61	2021-02-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203202-001	NCE	2019-02-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203202-001	ODE-61	2021-02-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203202-002	NCE	2019-02-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203202-002	ODE-61	2021-02-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203202-003	NCE	2019-02-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203202-003	ODE-61	2021-02-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203202-001	NCE	2019-02-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203202-001	ODE-61	2021-02-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203202-002	NCE	2019-02-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203202-002	ODE-61	2021-02-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203202-003	NCE	2019-02-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203202-003	ODE-61	2021-02-18	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Northera
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DROXIDOPA	200 mg/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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1490026	Internal RxNorm lookup
1490032	Internal RxNorm lookup
1490034	Internal RxNorm lookup
1490036	Internal RxNorm lookup
1490038	Internal RxNorm lookup
1490040	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2179f02c-48d7-48eb-8007-5ae43d8d16bc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
60631d48-5636-440b-b5b6-ec0ca1c1ff07	Product name	1	20210727
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67386-821-19	Northera	90 in 1 BOTTLE	CAPSULE	90		26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67386-821-19	EA - Each	67386-821	0f34d155-080b-4210-b306-b0d1c8e03bd5	1	2014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DROXIDOPA	ACTIVE INGREDIENT	J7A92W69L7	NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]	8
DROXIDOPA	ACTIVE MOIETY	J7A92W69L7	NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]	8
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]	8
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]	8
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]	8
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]	8
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]	8
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]	8
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK LLC]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67386-821	NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK PHARMACEUTICALS LLC]	25	Current NDC, Legacy NDC, 1 package rows	20241222_2179f02c-48d7-48eb-8007-5ae43d8d16bc.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
Northera	DROXIDOPA	Lundbeck Pharmaceuticals LLC	2179f02c-48d7-48eb-8007-5ae43d8d16bc	2019-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203202 application number: NDA203202 ndc (product): 67386-821

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1490026	droxidopa 100 MG Oral Capsule	PSN	2179f02c-48d7-48eb-8007-5ae43d8d16bc	26
1490034	droxidopa 200 MG Oral Capsule	PSN	2179f02c-48d7-48eb-8007-5ae43d8d16bc	26
1490038	droxidopa 300 MG Oral Capsule	PSN	2179f02c-48d7-48eb-8007-5ae43d8d16bc	26
1490032	Northera 100 MG Oral Capsule	PSN	2179f02c-48d7-48eb-8007-5ae43d8d16bc	26
1490036	Northera 200 MG Oral Capsule	PSN	2179f02c-48d7-48eb-8007-5ae43d8d16bc	26
1490040	Northera 300 MG Oral Capsule	PSN	2179f02c-48d7-48eb-8007-5ae43d8d16bc	26
1490032	droxidopa 100 MG Oral Capsule [Northera]	SBD	2179f02c-48d7-48eb-8007-5ae43d8d16bc	26
1490036	droxidopa 200 MG Oral Capsule [Northera]	SBD	2179f02c-48d7-48eb-8007-5ae43d8d16bc	26
1490040	droxidopa 300 MG Oral Capsule [Northera]	SBD	2179f02c-48d7-48eb-8007-5ae43d8d16bc	26
1490026	droxidopa 100 MG Oral Capsule	SCD	2179f02c-48d7-48eb-8007-5ae43d8d16bc	26
1490034	droxidopa 200 MG Oral Capsule	SCD	2179f02c-48d7-48eb-8007-5ae43d8d16bc	26
1490038	droxidopa 300 MG Oral Capsule	SCD	2179f02c-48d7-48eb-8007-5ae43d8d16bc	26
1490032	Northera 100 MG Oral Capsule	SY	2179f02c-48d7-48eb-8007-5ae43d8d16bc	26
1490036	Northera 200 MG Oral Capsule	SY	2179f02c-48d7-48eb-8007-5ae43d8d16bc	26
1490040	Northera 300 MG Oral Capsule	SY	2179f02c-48d7-48eb-8007-5ae43d8d16bc	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67386-821-19	67386082119	90 CAPSULE in 1 BOTTLE (67386-821-19)	90 capsule	2014-09-01	0000-00-00	No	No	Current