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#
Label contents#
Full prescribing information#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1490026 | droxidopa 100 MG Oral Capsule | PSN | 3 |
| 1490034 | droxidopa 200 MG Oral Capsule | PSN | 3 |
| 1490038 | droxidopa 300 MG Oral Capsule | PSN | 3 |
| 1490026 | droxidopa 100 MG Oral Capsule | SCD | 3 |
| 1490034 | droxidopa 200 MG Oral Capsule | SCD | 3 |
| 1490038 | droxidopa 300 MG Oral Capsule | SCD | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DROXIDOPA Pharmacologic Class Indexing | 4 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 60631d48-5636-440b-b5b6-ec0ca1c1ff07 | Product name | 1 | 20210727 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70771-1609-9 | Droxidopa | 90 in 1 BOTTLE | CAPSULE | 90 | 3 | |
| 70771-1610-9 | Droxidopa | 90 in 1 BOTTLE | CAPSULE | 90 | 3 | |
| 70771-1611-9 | Droxidopa | 90 in 1 BOTTLE | CAPSULE | 90 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70771-1609 | DROXIDOPA CAPSULE [ZYDUS LIFESCIENCES LIMITED] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241201_e9894e44-99ff-471a-bcc2-bfecd55a6559.zip |
| 70771-1610 | DROXIDOPA CAPSULE [ZYDUS LIFESCIENCES LIMITED] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241201_e9894e44-99ff-471a-bcc2-bfecd55a6559.zip |
| 70771-1611 | DROXIDOPA CAPSULE [ZYDUS LIFESCIENCES LIMITED] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241201_e9894e44-99ff-471a-bcc2-bfecd55a6559.zip |
Products#
Every source-derived product name is available through these pages.
- Droxidopa
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- FERROSOFERRIC OXIDE
- GELATIN
- MAGNESIUM STEARATE
- MANNITOL
- POTASSIUM HYDROXIDE
- PROPYLENE GLYCOL
- SHELLAC
- SODIUM LAURYL SULFATE
- STARCH, CORN
- TITANIUM DIOXIDE
- WATER
- FERRIC OXIDE RED
- FERRIC OXIDE YELLOW
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70771-1609 | 70771-1609-9 |
| 70771-1610 | 70771-1610-9 |
| 70771-1611 | 70771-1611-9 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211818-001 | DROXIDOPA | DROXIDOPA | 100MG | CAPSULE / ORAL | AB | 2021-02-18 | |
| A211818-002 | DROXIDOPA | DROXIDOPA | 200MG | CAPSULE / ORAL | AB | 2021-02-18 | |
| A211818-003 | DROXIDOPA | DROXIDOPA | 300MG | CAPSULE / ORAL | AB | 2021-02-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A211818-001 | AB |
| A211818-002 | AB |
| A211818-003 | 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211818-001 | DROXIDOPA | 100MG | CAPSULE / ORAL | AB | 2021-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211818-002 | DROXIDOPA | 200MG | CAPSULE / ORAL | AB | 2021-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211818-003 | DROXIDOPA | 300MG | CAPSULE / ORAL | AB | 2021-02-18 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A211818-001 | DROXIDOPA | 100MG | CAPSULE / ORAL | AB | 2021-02-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211818-002 | DROXIDOPA | 200MG | CAPSULE / ORAL | AB | 2021-02-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211818-003 | DROXIDOPA | 300MG | CAPSULE / ORAL | AB | 2021-02-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211818-001 | DROXIDOPA | 100MG | CAPSULE / ORAL | AB | 2021-02-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211818-002 | DROXIDOPA | 200MG | CAPSULE / ORAL | AB | 2021-02-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211818-003 | DROXIDOPA | 300MG | CAPSULE / ORAL | AB | 2021-02-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211818-001 | DROXIDOPA | 100MG | CAPSULE / ORAL | AB | 2021-02-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211818-002 | DROXIDOPA | 200MG | CAPSULE / ORAL | AB | 2021-02-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211818-003 | DROXIDOPA | 300MG | CAPSULE / ORAL | AB | 2021-02-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211818-001 | DROXIDOPA | 100MG | CAPSULE / ORAL | AB | 2021-02-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211818-002 | DROXIDOPA | 200MG | CAPSULE / ORAL | AB | 2021-02-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211818-003 | DROXIDOPA | 300MG | CAPSULE / ORAL | AB | 2021-02-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211818-001 | DROXIDOPA | 100MG | CAPSULE / ORAL | AB | 2021-02-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211818-002 | DROXIDOPA | 200MG | CAPSULE / ORAL | AB | 2021-02-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211818-003 | DROXIDOPA | 300MG | CAPSULE / ORAL | AB | 2021-02-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211818-001 | DROXIDOPA | 100MG | CAPSULE / ORAL | AB | 2021-02-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211818-002 | DROXIDOPA | 200MG | CAPSULE / ORAL | AB | 2021-02-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211818-003 | DROXIDOPA | 300MG | CAPSULE / ORAL | AB | 2021-02-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211818-001 | DROXIDOPA | 100MG | CAPSULE / ORAL | AB | 2021-02-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211818-002 | DROXIDOPA | 200MG | CAPSULE / ORAL | AB | 2021-02-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211818-003 | DROXIDOPA | 300MG | CAPSULE / ORAL | AB | 2021-02-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211818-001 | DROXIDOPA | 100MG | CAPSULE / ORAL | AB | 2021-02-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211818-002 | DROXIDOPA | 200MG | CAPSULE / ORAL | AB | 2021-02-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211818-003 | DROXIDOPA | 300MG | CAPSULE / ORAL | AB | 2021-02-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211818-001 | DROXIDOPA | 100MG | CAPSULE / ORAL | AB | 2021-02-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211818-002 | DROXIDOPA | 200MG | CAPSULE / ORAL | AB | 2021-02-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211818-003 | DROXIDOPA | 300MG | CAPSULE / ORAL | AB | 2021-02-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211818-001 | DROXIDOPA | 100MG | CAPSULE / ORAL | AB | 2021-02-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211818-002 | DROXIDOPA | 200MG | CAPSULE / ORAL | AB | 2021-02-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211818-003 | DROXIDOPA | 300MG | CAPSULE / ORAL | AB | 2021-02-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A211818-001 | DROXIDOPA | 100MG | CAPSULE / ORAL | AB | 2021-02-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A211818-002 | DROXIDOPA | 200MG | CAPSULE / ORAL | AB | 2021-02-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A211818-003 | DROXIDOPA | 300MG | CAPSULE / ORAL | AB | 2021-02-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211818-001 | DROXIDOPA | 100MG | CAPSULE / ORAL | AB | 2021-02-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211818-002 | DROXIDOPA | 200MG | CAPSULE / ORAL | AB | 2021-02-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211818-003 | DROXIDOPA | 300MG | CAPSULE / ORAL | AB | 2021-02-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211818-001 | DROXIDOPA | 100MG | CAPSULE / ORAL | AB | 2021-02-18 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211818-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211818-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211818-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A211818-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211818-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211818-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A211818-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211818-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211818-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211818-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211818-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211818-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A211818-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211818-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211818-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211818-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211818-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211818-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211818-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211818-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211818-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211818-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211818-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211818-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211818-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211818-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211818-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211818-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211818-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211818-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211818-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211818-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211818-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A211818-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A211818-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A211818-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211818-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211818-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211818-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211818-001 | AB | 1 | 301d65b070ca… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Droxidopa | DROXIDOPA | Zydus Lifesciences Limited | e9894e44-99ff-471a-bcc2-bfecd55a6559 | 2024-11-28 | 70771-1609-9 70771-1610-9 70771-1611-9 70771-1611 70771-1610 70771-1609 70771161009 70771160909 70771161109 2c98c6ce-80d6-4ec5-b0a8-8305bf6ac6eb e9894e44-99ff-471a-bcc2-bfecd55a6559 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.


