Midodrine Hydrochloride
- Product NDC
- 70985-006
- Requested package NDC
- 70985-006-01
- 11-digit product format
- 709850006
- Labeler code
- 70985
- Product ID
- 70985-006_cfd290fe-1a8c-c40c-e053-2995a90afb10
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Midodrine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Drug Ocean LLC
- Application
- ANDA207613
- Marketing category
- ANDA
- Marketing start
- 2020-06-19
- Marketing end
- 0000-00-00
- Substance
- MIDODRINE HYDROCHLORIDE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 70985-006 | 70985-006-01 | D | Discontinued by firm | 2026-08-17 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207613-001 | MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | AB | 2018-11-02 | |
| A207613-002 | MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-11-02 | |
| A207613-003 | MIDODRINE HYDROCHLORIDE | MIDODRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-11-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207613-001 | AB |
| A207613-002 | AB |
| A207613-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207613-001 | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | AB | 2018-11-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207613-002 | MIDODRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-11-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207613-003 | MIDODRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-11-02 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207613-001 | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | AB | 2018-11-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207613-002 | MIDODRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-11-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207613-003 | MIDODRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-11-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207613-001 | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | AB | 2018-11-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207613-002 | MIDODRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-11-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207613-003 | MIDODRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-11-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207613-001 | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | AB | 2018-11-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207613-002 | MIDODRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-11-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207613-003 | MIDODRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-11-02 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207613-001 | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | AB | 2018-11-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207613-002 | MIDODRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-11-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207613-003 | MIDODRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-11-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207613-001 | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | AB | 2018-11-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207613-002 | MIDODRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-11-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207613-003 | MIDODRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-11-02 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207613-001 | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | AB | 2018-11-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207613-002 | MIDODRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-11-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207613-003 | MIDODRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-11-02 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207613-001 | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | AB | 2018-11-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207613-002 | MIDODRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-11-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207613-003 | MIDODRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-11-02 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207613-001 | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | AB | 2018-11-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207613-002 | MIDODRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-11-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207613-003 | MIDODRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-11-02 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207613-001 | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | AB | 2018-11-02 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207613-002 | MIDODRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-11-02 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207613-003 | MIDODRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-11-02 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207613-001 | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | AB | 2018-11-02 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207613-002 | MIDODRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-11-02 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207613-003 | MIDODRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-11-02 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207613-001 | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | AB | 2018-11-02 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207613-002 | MIDODRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-11-02 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207613-003 | MIDODRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-11-02 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207613-001 | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | AB | 2018-11-02 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207613-002 | MIDODRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-11-02 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207613-003 | MIDODRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-11-02 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207613-001 | MIDODRINE HYDROCHLORIDE | 2.5MG | TABLET / ORAL | AB | 2018-11-02 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207613-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207613-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207613-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A207613-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207613-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207613-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207613-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207613-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207613-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207613-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207613-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207613-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207613-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207613-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207613-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207613-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207613-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207613-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207613-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207613-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207613-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207613-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207613-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207613-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207613-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207613-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207613-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207613-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207613-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207613-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207613-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207613-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207613-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207613-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207613-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207613-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207613-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207613-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207613-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207613-001 | AB | 1 | 1e350fbaab3a… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ee08dc62-0af6-bb42-639c-6cdc4aad4b08 | Product name | 6 | 20250801 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Midodrine Hydrochloride | MIDODRINE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | ffd4dfb9-a6d8-4c81-8b8c-8228d9e2f93e | 2025-05-30 | Boxed warning, Warnings, Adverse reactions | 207613 ANDA207613 |
| Midodrine Hydrochloride | MIDODRINE HYDROCHLORIDE | Umasuto, LLC | 4f5e1689-9691-471b-a39c-26120d6ce073 | 2025-03-06 | Boxed warning, Warnings, Adverse reactions | 207613 ANDA207613 |
| Midodrine Hydrochloride | MIDODRINE HYDROCHLORIDE | Bryant Ranch Prepack | 2be17e48-8258-4f29-914b-7f0fe9ace7a1 | 2020-10-16 | Boxed warning, Warnings, Adverse reactions | 207613 ANDA207613 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70985-006-01 | 70985000601 | 100 TABLET in 1 BOTTLE (70985-006-01) | 100 tablet | 2020-06-19 | 0000-00-00 | No | No | Current |