Droxidopa Capsules

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-11-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 21:18:26

Label at a glance#

ProductDroxidopa
Active ingredientDROXIDOPA
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1609-9

Droxidopa Capsules, 100 mg

90 Capsules

Rx only

Droxi-100mg-image
Droxi-100mg-image

NDC 70771-1610-9

Droxidopa Capsules, 200 mg

90 Capsules

Rx only

droxi-200mg-image
droxi-200mg-image

NDC 70771-1611-9

Droxidopa Capsules, 300 mg

90 Capsules

Rx only

Droxi-300mg-image
Droxi-300mg-image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1490026droxidopa 100 MG Oral CapsulePSN3
1490034droxidopa 200 MG Oral CapsulePSN3
1490038droxidopa 300 MG Oral CapsulePSN3
1490026droxidopa 100 MG Oral CapsuleSCD3
1490034droxidopa 200 MG Oral CapsuleSCD3
1490038droxidopa 300 MG Oral CapsuleSCD3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DROXIDOPA Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60631d48-5636-440b-b5b6-ec0ca1c1ff07Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1609-9Droxidopa90 in 1 BOTTLECAPSULE903
70771-1610-9Droxidopa90 in 1 BOTTLECAPSULE903
70771-1611-9Droxidopa90 in 1 BOTTLECAPSULE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1609DROXIDOPA CAPSULE [ZYDUS LIFESCIENCES LIMITED]3Current NDC, Legacy NDC, 1 package rows20241201_e9894e44-99ff-471a-bcc2-bfecd55a6559.zip
70771-1610DROXIDOPA CAPSULE [ZYDUS LIFESCIENCES LIMITED]3Current NDC, Legacy NDC, 1 package rows20241201_e9894e44-99ff-471a-bcc2-bfecd55a6559.zip
70771-1611DROXIDOPA CAPSULE [ZYDUS LIFESCIENCES LIMITED]3Current NDC, Legacy NDC, 1 package rows20241201_e9894e44-99ff-471a-bcc2-bfecd55a6559.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-160970771-1609-9
70771-161070771-1610-9
70771-161170771-1611-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A211818-001DROXIDOPADROXIDOPA100MGCAPSULE / ORALAB2021-02-18
A211818-002DROXIDOPADROXIDOPA200MGCAPSULE / ORALAB2021-02-18
A211818-003DROXIDOPADROXIDOPA300MGCAPSULE / 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
A211818-001AB
A211818-002AB
A211818-003AB

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 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211818-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-1884e616aacf4f…
2026-09-14 22:38:342026-08A211818-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-1884e616aacf4f…
2026-09-14 22:38:342026-08A211818-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-1884e616aacf4f…
2026-08-18 06:07:402026-07A211818-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-18caaa826d4ba7…
2026-08-18 06:07:402026-07A211818-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-18caaa826d4ba7…
2026-08-18 06:07:402026-07A211818-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211818-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211818-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211818-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211818-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211818-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211818-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211818-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211818-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211818-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211818-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211818-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211818-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211818-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211818-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211818-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211818-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211818-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211818-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211818-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211818-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211818-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211818-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211818-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211818-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211818-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211818-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211818-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211818-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A211818-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A211818-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211818-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211818-002DROXIDOPA200MGCAPSULE / ORALAB2021-02-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211818-003DROXIDOPA300MGCAPSULE / ORALAB2021-02-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211818-001DROXIDOPA100MGCAPSULE / ORALAB2021-02-18301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A211818-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A211818-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A211818-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A211818-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211818-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211818-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211818-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211818-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211818-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211818-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211818-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211818-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211818-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211818-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211818-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211818-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211818-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211818-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211818-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211818-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211818-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211818-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211818-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211818-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211818-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211818-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211818-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211818-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211818-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211818-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211818-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211818-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211818-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211818-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211818-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211818-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211818-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211818-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211818-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211818-001AB1301d65b070ca…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DroxidopaDROXIDOPAZydus Lifesciences Limitede9894e44-99ff-471a-bcc2-bfecd55a65592024-11-28Exact identifier
ndc (package): 70771-1609-9
ndc (package): 70771-1610-9
ndc (package): 70771-1611-9
ndc (product): 70771-1611
ndc (product): 70771-1610
ndc (product): 70771-1609
ndc11 (package): 70771161009
ndc11 (package): 70771160909
ndc11 (package): 70771161109
spl id: 2c98c6ce-80d6-4ec5-b0a8-8305bf6ac6eb
spl set id: e9894e44-99ff-471a-bcc2-bfecd55a6559

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.