DEXMEDETOMIDINE
- Product NDC
- 57884-3091
- 11-digit product format
- 578843091
- Labeler code
- 57884
- Product ID
- 57884-3091_a138d0e4-4983-6782-e053-2a95a90ac30e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DEXMEDETOMIDINE
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Jiangsu Hengrui Medicine Co., Ltd.
- Application
- ANDA209065
- Marketing category
- ANDA
- Marketing start
- 2017-09-19
- Marketing end
- 0000-00-00
- Substance
- DEXMEDETOMIDINE HYDROCHLORIDE
- Active strength
- 100 ug/mL
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209065-001 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | 2017-09-19 | ||
| A209065-002 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | |
| A209065-003 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | |
| A209065-004 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209065-002 | AP |
| A209065-003 | AP |
| A209065-004 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209065-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2017-09-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209065-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209065-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209065-004 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209065-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2017-09-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209065-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209065-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209065-004 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209065-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2017-09-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209065-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209065-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209065-004 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209065-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2017-09-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209065-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209065-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209065-004 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209065-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2017-09-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209065-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209065-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209065-004 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209065-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2017-09-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209065-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209065-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209065-004 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209065-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2017-09-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209065-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209065-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209065-004 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209065-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2017-09-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209065-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209065-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209065-004 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209065-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2017-09-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209065-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209065-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209065-004 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209065-001 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2017-09-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209065-002 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209065-003 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209065-004 | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | 2020-06-12 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209065-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209065-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209065-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209065-004 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209065-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209065-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209065-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209065-004 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209065-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209065-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209065-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209065-004 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209065-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209065-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209065-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209065-004 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209065-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209065-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209065-003 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209065-004 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209065-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209065-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209065-003 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209065-004 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209065-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209065-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209065-003 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209065-004 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209065-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209065-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209065-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209065-004 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209065-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209065-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209065-003 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209065-004 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209065-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209065-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209065-003 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209065-004 | AP | 1 | d06236e962d9… |
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 |
|---|---|---|---|---|---|---|
| Dexmedetomidine | DEXMEDETOMIDINE | Avenacy Inc. | eee6145b-d83f-4596-92d3-733934d8a3a4 | 2026-08-05 | Warnings, Adverse reactions | 209065 ANDA209065 |
| DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | ProPharma Distribution | 42caba25-dd87-040c-e063-6294a90a7a12 | 2025-11-04 | Warnings, Adverse reactions | 209065 ANDA209065 |
| DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | Sandoz Inc. | 809e8f77-390f-4cc8-8c8a-4f67a249c9df | 2023-06-12 | Warnings, Adverse reactions | 209065 ANDA209065 |