PRECEDEX
- Product NDC
- 52584-638
- 11-digit product format
- 525840638
- Labeler code
- 52584
- Product ID
- 52584-638_7cfa5459-ca61-4057-8629-4c19a3e5fe1f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DEXMEDETOMIDINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- General Injectables and Vaccines, Inc.
- Application
- NDA021038
- Marketing category
- NDA
- Marketing start
- 2018-07-02
- Marketing end
- 2023-09-01
- 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
- 0000-00-00
- 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 product | product | 52584-638 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 52584-638 | 52584-638-02 | D | Discontinued by firm | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52584-638-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52584-638-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52584-638-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52584-638-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52584-638-02 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52584-638-02 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52584-638-02 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52584-638-02 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52584-638-02 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 52584-638-02 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 52584-638-02 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 52584-638-02 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021038-001 | PRECEDEX | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 1999-12-17 |
| N021038-002 | PRECEDEX | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2013-03-13 |
| N021038-003 | PRECEDEX | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2013-03-13 |
| N021038-004 | PRECEDEX | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2014-11-14 |
| N021038-005 | PRECEDEX | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2020-01-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021038-001 | AP |
| N021038-002 | AP |
| N021038-003 | AP |
| N021038-004 | AP |
| N021038-005 | AP |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N021038-002 | 10016396 | 2032-01-04 | Drug product | 2018-08-09 | |
| N021038-002 | 8242158 | 2032-01-04 | Drug product | 2013-05-21 | |
| N021038-002 | 8338470 | 2032-01-04 | Drug product | 2013-05-21 | |
| N021038-002 | 8455527 | 2032-01-04 | U-421 | ||
| N021038-002 | 8648106 | 2032-01-04 | Drug product | 2014-03-05 | |
| N021038-002 | 9320712 | 2032-01-04 | Drug product | 2016-09-19 | |
| N021038-002 | 9616049 | 2032-01-04 | Drug product | 2017-05-09 | |
| N021038-002 | 8242158*PED | 2032-07-04 | Pediatric extension | ||
| N021038-002 | 8338470*PED | 2032-07-04 | Pediatric extension | ||
| N021038-002 | 8455527*PED | 2032-07-04 | Pediatric extension | ||
| N021038-002 | 8648106*PED | 2032-07-04 | Pediatric extension | ||
| N021038-002 | 9320712*PED | 2032-07-04 | Pediatric extension | ||
| N021038-002 | 9616049*PED | 2032-07-04 | Pediatric extension | ||
| N021038-003 | 10016396 | 2032-01-04 | Drug product | 2018-08-09 | |
| N021038-003 | 8242158 | 2032-01-04 | Drug product | ||
| N021038-003 | 8338470 | 2032-01-04 | Drug product | ||
| N021038-003 | 8455527 | 2032-01-04 | U-421 | ||
| N021038-003 | 8648106 | 2032-01-04 | Drug product | 2014-03-05 | |
| N021038-003 | 9320712 | 2032-01-04 | Drug product | 2016-09-19 | |
| N021038-003 | 9616049 | 2032-01-04 | Drug product | 2017-05-09 | |
| N021038-003 | 8242158*PED | 2032-07-04 | Pediatric extension | ||
| N021038-003 | 8338470*PED | 2032-07-04 | Pediatric extension | ||
| N021038-003 | 8455527*PED | 2032-07-04 | Pediatric extension | ||
| N021038-003 | 8648106*PED | 2032-07-04 | Pediatric extension | ||
| N021038-003 | 9320712*PED | 2032-07-04 | Pediatric extension | ||
| N021038-003 | 9616049*PED | 2032-07-04 | Pediatric extension | ||
| N021038-004 | 8242158 | 2032-01-04 | Drug product | 2015-01-30 | |
| N021038-004 | 8338470 | 2032-01-04 | Drug product | 2015-01-30 | |
| N021038-004 | 8455527 | 2032-01-04 | U-421 | 2015-01-30 | |
| N021038-004 | 8648106 | 2032-01-04 | Drug product | 2015-01-30 | |
| N021038-004 | 9320712 | 2032-01-04 | Drug product | 2016-09-19 | |
| N021038-004 | 9616049 | 2032-01-04 | Drug product | 2017-05-09 | |
| N021038-004 | 8242158*PED | 2032-07-04 | Pediatric extension | ||
| N021038-004 | 8338470*PED | 2032-07-04 | Pediatric extension | ||
| N021038-004 | 8455527*PED | 2032-07-04 | Pediatric extension | ||
| N021038-004 | 8648106*PED | 2032-07-04 | Pediatric extension | ||
| N021038-004 | 9320712*PED | 2032-07-04 | Pediatric extension | ||
| N021038-004 | 9616049*PED | 2032-07-04 | Pediatric extension |
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 | N021038-001 | PRECEDEX | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 1999-12-17 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021038-002 | PRECEDEX | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2013-03-13 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021038-003 | PRECEDEX | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2013-03-13 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021038-004 | PRECEDEX | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2014-11-14 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021038-005 | PRECEDEX | EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2020-01-31 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021038-001 | PRECEDEX | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 1999-12-17 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021038-002 | PRECEDEX | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2013-03-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021038-003 | PRECEDEX | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2013-03-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021038-004 | PRECEDEX | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2014-11-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021038-005 | PRECEDEX | EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2020-01-31 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021038-001 | PRECEDEX | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 1999-12-17 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021038-002 | PRECEDEX | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2013-03-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021038-003 | PRECEDEX | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2013-03-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021038-004 | PRECEDEX | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2014-11-14 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021038-005 | PRECEDEX | EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2020-01-31 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021038-001 | PRECEDEX | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 1999-12-17 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021038-002 | PRECEDEX | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2013-03-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021038-003 | PRECEDEX | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2013-03-13 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021038-004 | PRECEDEX | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2014-11-14 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021038-005 | PRECEDEX | EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2020-01-31 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021038-001 | PRECEDEX | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 1999-12-17 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021038-002 | PRECEDEX | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2013-03-13 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021038-003 | PRECEDEX | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2013-03-13 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021038-004 | PRECEDEX | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2014-11-14 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021038-005 | PRECEDEX | EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2020-01-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021038-001 | PRECEDEX | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 1999-12-17 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021038-002 | PRECEDEX | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2013-03-13 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021038-003 | PRECEDEX | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2013-03-13 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021038-004 | PRECEDEX | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2014-11-14 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021038-005 | PRECEDEX | EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2020-01-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021038-001 | PRECEDEX | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 1999-12-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021038-002 | PRECEDEX | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2013-03-13 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021038-003 | PRECEDEX | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2013-03-13 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021038-004 | PRECEDEX | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2014-11-14 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021038-005 | PRECEDEX | EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2020-01-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021038-001 | PRECEDEX | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 1999-12-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021038-002 | PRECEDEX | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2013-03-13 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021038-003 | PRECEDEX | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2013-03-13 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021038-004 | PRECEDEX | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2014-11-14 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021038-005 | PRECEDEX | EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) | INJECTABLE / INJECTION | RLD, RS | 2020-01-31 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N021038-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021038-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021038-003 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021038-004 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021038-005 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021038-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021038-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021038-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021038-004 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021038-005 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021038-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021038-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021038-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021038-004 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021038-005 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021038-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021038-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021038-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021038-004 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021038-005 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021038-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021038-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021038-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021038-004 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021038-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021038-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021038-003 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021038-004 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021038-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021038-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021038-003 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021038-004 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021038-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021038-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021038-003 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021038-004 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021038-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021038-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021038-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021038-004 | AP | 1 | 5bbf6a4d5a75… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N021038-002 | 10016396 | 2032-01-04 | Drug product | 2018-08-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021038-002 | 8242158 | 2032-01-04 | Drug product | 2013-05-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021038-002 | 8338470 | 2032-01-04 | Drug product | 2013-05-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021038-002 | 8455527 | 2032-01-04 | U-421 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-002 | 8648106 | 2032-01-04 | Drug product | 2014-03-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021038-002 | 9320712 | 2032-01-04 | Drug product | 2016-09-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021038-002 | 9616049 | 2032-01-04 | Drug product | 2017-05-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021038-002 | 8242158*PED | 2032-07-04 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-002 | 8338470*PED | 2032-07-04 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-002 | 8455527*PED | 2032-07-04 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-002 | 8648106*PED | 2032-07-04 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-002 | 9320712*PED | 2032-07-04 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-002 | 9616049*PED | 2032-07-04 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-003 | 10016396 | 2032-01-04 | Drug product | 2018-08-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021038-003 | 8242158 | 2032-01-04 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-003 | 8338470 | 2032-01-04 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-003 | 8455527 | 2032-01-04 | U-421 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-003 | 8648106 | 2032-01-04 | Drug product | 2014-03-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021038-003 | 9320712 | 2032-01-04 | Drug product | 2016-09-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021038-003 | 9616049 | 2032-01-04 | Drug product | 2017-05-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021038-003 | 8242158*PED | 2032-07-04 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-003 | 8338470*PED | 2032-07-04 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-003 | 8455527*PED | 2032-07-04 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-003 | 8648106*PED | 2032-07-04 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-003 | 9320712*PED | 2032-07-04 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-003 | 9616049*PED | 2032-07-04 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-004 | 8242158 | 2032-01-04 | Drug product | 2015-01-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021038-004 | 8338470 | 2032-01-04 | Drug product | 2015-01-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021038-004 | 8455527 | 2032-01-04 | U-421 | 2015-01-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021038-004 | 8648106 | 2032-01-04 | Drug product | 2015-01-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021038-004 | 9320712 | 2032-01-04 | Drug product | 2016-09-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021038-004 | 9616049 | 2032-01-04 | Drug product | 2017-05-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021038-004 | 8242158*PED | 2032-07-04 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-004 | 8338470*PED | 2032-07-04 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-004 | 8455527*PED | 2032-07-04 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-004 | 8648106*PED | 2032-07-04 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-004 | 9320712*PED | 2032-07-04 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021038-004 | 9616049*PED | 2032-07-04 | Pediatric extension | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021038-002 | 10016396 | 2032-01-04 | Drug product | 2018-08-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021038-002 | 8242158 | 2032-01-04 | Drug product | 2013-05-21 | 011fe1cb6892… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021038-001 | NPP | 2025-12-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021038-002 | NPP | 2025-12-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021038-003 | NPP | 2025-12-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021038-004 | NPP | 2025-12-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021038-005 | NPP | 2025-12-16 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021038-001 | NPP | 2025-12-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021038-002 | NPP | 2025-12-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021038-003 | NPP | 2025-12-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021038-004 | NPP | 2025-12-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021038-005 | NPP | 2025-12-16 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021038-001 | NPP | 2025-12-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021038-002 | NPP | 2025-12-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021038-003 | NPP | 2025-12-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021038-004 | NPP | 2025-12-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021038-005 | NPP | 2025-12-16 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021038-001 | NPP | 2025-12-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021038-002 | NPP | 2025-12-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021038-003 | NPP | 2025-12-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021038-004 | NPP | 2025-12-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021038-005 | NPP | 2025-12-16 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021038-001 | NPP | 2025-12-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021038-002 | NPP | 2025-12-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021038-003 | NPP | 2025-12-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021038-004 | NPP | 2025-12-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021038-005 | NPP | 2025-12-16 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021038-001 | NPP | 2025-12-16 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021038-002 | NPP | 2025-12-16 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021038-003 | NPP | 2025-12-16 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021038-004 | NPP | 2025-12-16 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021038-005 | NPP | 2025-12-16 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021038-001 | NPP | 2025-12-16 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021038-002 | NPP | 2025-12-16 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021038-003 | NPP | 2025-12-16 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021038-004 | NPP | 2025-12-16 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021038-005 | NPP | 2025-12-16 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021038-001 | NPP | 2025-12-16 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021038-002 | NPP | 2025-12-16 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021038-003 | NPP | 2025-12-16 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021038-004 | NPP | 2025-12-16 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021038-005 | NPP | 2025-12-16 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|---|
| Precedex | DEXMEDETOMIDINE HYDROCHLORIDE | Hospira, Inc. | 92b7ddaa-e45a-4b64-a802-bb5df8771dd6 | 2026-06-17 | Warnings, Adverse reactions | 021038 NDA021038 |
| Precedex | DEXMEDETOMIDINE HYDROCHLORIDE | Hospira, Inc. | 4419162d-81d4-49bd-96de-1729440bdb74 | 2026-06-09 | Warnings, Adverse reactions | 021038 NDA021038 |
| PRECEDEX | DEXMEDETOMIDINE HYDROCHLORIDE | Henry Schein, Inc. | 9eb336de-5fa5-4b46-b40b-a7ca5a0864bd | 2026-05-21 | Warnings, Adverse reactions | 021038 NDA021038 |
| Precedex | DEXMEDETOMIDINE HYDROCHLORIDE | Hospira, Inc. | 548a88c0-afda-427e-75ac-5af0cfa2224c | 2026-05-20 | Warnings, Adverse reactions | 021038 NDA021038 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52584-638-02 | 52584063802 | 1 VIAL in 1 BAG (52584-638-02) > 2 mL in 1 VIAL | 1 vial | 2018-07-02 | 0000-00-00 | No | No | Current |