Droxidopa

Product NDC
72205-073
Requested package NDC
72205-073-90
11-digit product format
722050073
Labeler code
72205
Product ID
72205-073_e30e4875-830c-48ed-a6ee-0bddcceece84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Droxidopa
Dosage form
CAPSULE
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA211741
Marketing category
ANDA
Marketing start
2021-02-19
Substance
DROXIDOPA
Active strength
200 mg/1
Pharmacologic classes
Catecholamines [CS], Increased Blood Pressure [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211741-001DROXIDOPADROXIDOPA100MGCAPSULE / ORALAB2021-02-18
A211741-002DROXIDOPADROXIDOPA200MGCAPSULE / ORALAB2021-02-18
A211741-003DROXIDOPADROXIDOPA300MGCAPSULE / ORALAB2021-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211741-001AB
A211741-002AB
A211741-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211741-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211741-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211741-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211741-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211741-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211741-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211741-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211741-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211741-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211741-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211741-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211741-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211741-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211741-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211741-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211741-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211741-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211741-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211741-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211741-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211741-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211741-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211741-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211741-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211741-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211741-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211741-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211741-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A211741-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A211741-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211741-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211741-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211741-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211741-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211741-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211741-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211741-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211741-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211741-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211741-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-188072bd15b7f6…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211741-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211741-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211741-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211741-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211741-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211741-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211741-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211741-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211741-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211741-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211741-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211741-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211741-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211741-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211741-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211741-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211741-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211741-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211741-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211741-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211741-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211741-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211741-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211741-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211741-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211741-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211741-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211741-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211741-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211741-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211741-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211741-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211741-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211741-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211741-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211741-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211741-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211741-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211741-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211741-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Droxidopa
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DROXIDOPA200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J7A92W69L7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1490026Internal RxNorm lookup
1490034Internal RxNorm lookup
1490038Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
381ffe44-d5d8-4380-a3cd-6d6a5e9ef55dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60631d48-5636-440b-b5b6-ec0ca1c1ff07Product name120210727
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-073-05Droxidopa500 in 1 BOTTLECAPSULE5002
72205-073-90Droxidopa90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-073-90EA - Each72205-073742f459b-1fb2-4165-9806-f6da858ceb5f12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-073DROXIDOPA CAPSULE [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, Legacy NDC, 2 package rows20210222_381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DroxidopaDROXIDOPANovadoz Pharmaceuticals LLC381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d2026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211741
application number: ANDA211741
ndc (package): 72205-073-90
ndc (product): 72205-073
ndc11 (package): 72205007390
DroxidopaDROXIDOPAMAJOR PHARMACEUTICALS04b1f69d-ebba-43b9-8ecd-4f6be7c8a0a02024-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211741
application number: ANDA211741

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1490026droxidopa 100 MG Oral CapsulePSN381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d2
1490034droxidopa 200 MG Oral CapsulePSN381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d2
1490038droxidopa 300 MG Oral CapsulePSN381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d2
1490026droxidopa 100 MG Oral CapsuleSCD381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d2
1490034droxidopa 200 MG Oral CapsuleSCD381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d2
1490038droxidopa 300 MG Oral CapsuleSCD381ffe44-d5d8-4380-a3cd-6d6a5e9ef55d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-073-907220500739090 CAPSULE in 1 BOTTLE (72205-073-90) 90 capsule2021-02-190000-00-00NoNoCurrent