Home NDC 70069-758 Dexmedetomidine Hydrochloride
Product NDC 70069-758
11-digit product format 700690758
Labeler code 70069
Product ID 70069-758_6a1a2c33-1467-4eb0-adc6-6e21771fbf6b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexmedetomidine Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Somerset Therapeutics, LLC
Application ANDA218112
Marketing category ANDA
Marketing start 2024-09-26
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218112-001 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 A218112-002 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
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 2026-08-18 06:07:40 2026-07 A218112-001 DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218112-002 DEXMEDETOMIDINE HYDROCHLORIDE EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218112-001 DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218112-002 DEXMEDETOMIDINE HYDROCHLORIDE EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218112-001 DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218112-002 DEXMEDETOMIDINE HYDROCHLORIDE EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218112-001 DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218112-002 DEXMEDETOMIDINE HYDROCHLORIDE EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218112-001 DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218112-002 DEXMEDETOMIDINE HYDROCHLORIDE EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218112-001 DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218112-002 DEXMEDETOMIDINE HYDROCHLORIDE EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218112-001 DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218112-002 DEXMEDETOMIDINE HYDROCHLORIDE EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218112-001 DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218112-002 DEXMEDETOMIDINE HYDROCHLORIDE EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218112-001 DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218112-002 DEXMEDETOMIDINE HYDROCHLORIDE EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218112-001 DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218112-002 DEXMEDETOMIDINE HYDROCHLORIDE EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218112-001 DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218112-002 DEXMEDETOMIDINE HYDROCHLORIDE EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) SOLUTION / INTRAVENOUS AP 2024-09-24 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218112-001 CGT 2025-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218112-002 CGT 2025-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218112-001 CGT 2025-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218112-002 CGT 2025-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218112-001 CGT 2025-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218112-002 CGT 2025-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218112-001 CGT 2025-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218112-002 CGT 2025-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218112-001 CGT 2025-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218112-002 CGT 2025-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218112-001 CGT 2025-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218112-002 CGT 2025-03-30 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218112-001 CGT 2025-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218112-002 CGT 2025-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218112-001 CGT 2025-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218112-002 CGT 2025-03-30 d06236e962d9…
Additional Listing Data#
Finished product Yes
Brand name base Dexmedetomidine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXMEDETOMIDINE HYDROCHLORIDE 100 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1788947 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 70069-758-04 Dexmedetomidine Hydrochloride 4 in 1 CARTON INJECTION, SOLUTION 4 5 70069-758-04 Dexmedetomidine Hydrochloride 4 mL in 1 VIAL INJECTION, SOLUTION 4 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70069-758 DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC] 5 Current NDC, 2 package rows 20240927_649e777b-9b30-4f1e-9fb9-6bba57580976.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70069-758-04 70069075804 4 VIAL in 1 CARTON (70069-758-04) / 4 mL in 1 VIAL 4 vial 2024-09-26 No No Current