Home NDC 0409-7875 Precedex
Product NDC 0409-7875
11-digit product format 004097875
Labeler code 0409
Product ID 0409-7875_3c5274fd-6597-4b88-babc-92e4e16c6329
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DEXMEDETOMIDINE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application NDA021038
Marketing category NDA
Marketing start 2025-03-24
Substance DEXMEDETOMIDINE HYDROCHLORIDE
Active strength 4 ug/mL
Pharmacologic classes Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Precedex
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1018WH7F9I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 284397 Internal RxNorm lookup 309710 Internal RxNorm lookup 1718900 Internal RxNorm lookup 1718902 Internal RxNorm lookup 1718906 Internal RxNorm lookup 1718907 Internal RxNorm lookup 1718909 Internal RxNorm lookup 1718910 Internal RxNorm lookup 2396891 Internal RxNorm lookup 2396892 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0409-7875-01 Precedex 250 mL in 1 BAG INJECTION, SOLUTION 250 59 0409-7875-12 Precedex 12 in 1 CASE INJECTION, SOLUTION 12 59 0409-7875-12 Precedex 1 in 1 POUCH INJECTION, SOLUTION 1 59
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXMEDETOMIDINE HYDROCHLORIDE ACTIVE INGREDIENT 1018WH7F9I PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 27 DEXMEDETOMIDINE ACTIVE MOIETY 67VB76HONO PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 27 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 27 WATER INACTIVE INGREDIENT 059QF0KO0R PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 27
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-7875 PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 53 Current NDC, 3 package rows 20250326_548a88c0-afda-427e-75ac-5af0cfa2224c.zip
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 · 4 matching rows.
Brand, Generic, Manufacturer table 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 Exact identifier application applno (NDA): 021038 application number: NDA021038 Precedex DEXMEDETOMIDINE HYDROCHLORIDE Hospira, Inc. 4419162d-81d4-49bd-96de-1729440bdb74 2026-06-09 Warnings, Adverse reactions Exact identifier application applno (NDA): 021038 application number: NDA021038 PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE Henry Schein, Inc. 9eb336de-5fa5-4b46-b40b-a7ca5a0864bd 2026-05-21 Warnings, Adverse reactions Exact identifier application applno (NDA): 021038 application number: NDA021038 Precedex DEXMEDETOMIDINE HYDROCHLORIDE Hospira, Inc. 548a88c0-afda-427e-75ac-5af0cfa2224c 2026-05-20 Warnings, Adverse reactions Exact identifier application applno (NDA): 021038 application number: NDA021038 ndc (product): 0409-7875
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0409-7875-01 00409787501 250 mL in 1 BAG 250 ml Historical 0409-7875-12 00409787512 12 POUCH in 1 CASE (0409-7875-12) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-7875-01) 12 pouch 2025-03-24 No No Current