Home NDC 70069-027 Buprenorphine Hydrochloride
Product NDC 70069-027
11-digit product format 700690027
Labeler code 70069
Product ID 70069-027_abc53fa8-3d75-47b5-bfb1-d61872c1ddb4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Buprenorphine Hydrochloride
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Somerset Therapeutics, LLC
Application ANDA219302
Marketing category ANDA
Marketing start 2025-02-11
Substance BUPRENORPHINE HYDROCHLORIDE
Active strength .324 mg/mL
Pharmacologic classes Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA schedule CIII
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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219302-001 BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 2025-01-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219302-001 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 table 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 A219302-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 2025-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219302-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 2025-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219302-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 2025-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219302-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 2025-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219302-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 2025-01-30 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219302-001 BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML INJECTABLE / INJECTION AP 2025-01-30 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Buprenorphine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPRENORPHINE HYDROCHLORIDE .324 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 56W8MW3EN1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238129 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 70069-027-05 Buprenorphine Hydrochloride 1 mL in 1 VIAL INJECTION 1 3 70069-027-05 Buprenorphine Hydrochloride 5 in 1 CARTON INJECTION 5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70069-027 BUPRENORPHINE HYDROCHLORIDE INJECTION [SOMERSET THERAPEUTICS, LLC] 3 Current NDC, 2 package rows 20250213_74e40c51-853b-4e7f-b3cb-a27af29e1cbf.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 70069-027-05 70069002705 5 VIAL in 1 CARTON (70069-027-05) / 1 mL in 1 VIAL 5 vial 2025-02-11 No No Current