Home DailyMed c04c27d3-e418-4b0b-8aff-e5222f358eb7 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2013-05-02
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 04:08:10 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 · 5 matching rows.
Application-product, Trade name, Ingredient table 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# Current TE-code rows page 1 of 1 · 5 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 38 matching rows.
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 6 · 211 observed states.
Captured, Edition, Application-product table 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 N021038-001 PRECEDEX EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE / INJECTION AP RLD, RS 1999-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-002 PRECEDEX EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE / INJECTION AP RLD, RS 2013-03-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-003 PRECEDEX EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE / INJECTION AP RLD, RS 2013-03-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-004 PRECEDEX EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) INJECTABLE / INJECTION AP RLD, RS 2014-11-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-005 PRECEDEX EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) INJECTABLE / INJECTION AP RLD, RS 2020-01-31 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 178 observed states.
Observed Orange Book patent history# Patent history page 1 of 42 · 1,666 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N021038-002 10016396 2032-01-04 Drug product 2018-08-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-002 8242158 2032-01-04 Drug product 2013-05-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-002 8338470 2032-01-04 Drug product 2013-05-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-002 8455527 2032-01-04 U-421 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-002 8648106 2032-01-04 Drug product 2014-03-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-002 9320712 2032-01-04 Drug product 2016-09-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-002 9616049 2032-01-04 Drug product 2017-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-002 8242158*PED 2032-07-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-002 8338470*PED 2032-07-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-002 8455527*PED 2032-07-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-002 8648106*PED 2032-07-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-002 9320712*PED 2032-07-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-002 9616049*PED 2032-07-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-003 10016396 2032-01-04 Drug product 2018-08-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-003 8242158 2032-01-04 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-003 8338470 2032-01-04 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-003 8455527 2032-01-04 U-421 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-003 8648106 2032-01-04 Drug product 2014-03-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-003 9320712 2032-01-04 Drug product 2016-09-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-003 9616049 2032-01-04 Drug product 2017-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-003 8242158*PED 2032-07-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-003 8338470*PED 2032-07-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-003 8455527*PED 2032-07-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-003 8648106*PED 2032-07-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-003 9320712*PED 2032-07-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-003 9616049*PED 2032-07-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-004 8242158 2032-01-04 Drug product 2015-01-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-004 8338470 2032-01-04 Drug product 2015-01-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-004 8455527 2032-01-04 U-421 2015-01-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-004 8648106 2032-01-04 Drug product 2015-01-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-004 9320712 2032-01-04 Drug product 2016-09-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-004 9616049 2032-01-04 Drug product 2017-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-004 8242158*PED 2032-07-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-004 8338470*PED 2032-07-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-004 8455527*PED 2032-07-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-004 8648106*PED 2032-07-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-004 9320712*PED 2032-07-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021038-004 9616049*PED 2032-07-04 Pediatric extension 84e616aacf4f…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…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 105 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.