FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Buprenorphine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE HYDROCHLORIDE.324 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii56W8MW3EN1
Rxcui238129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
68654759-f50b-79ef-24c5-544d94fe7d87Product name320251114
08a295bb-88df-4ab0-a120-a75a789a74f1Product name120231013
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
100316cc-94a9-474e-97ad-9b5c6ddec605Product name520230125
539bc5d3-546b-4af6-9c31-058ce6c459d3Product name220220210
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
31e16ab2-c562-4617-a3e8-ed285320e16eProduct name120180201
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
a5920611-4285-f024-69b9-39ff338b81eaProduct name520170609
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4Product name120160712
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-027-05Buprenorphine Hydrochloride1 mL in 1 VIALINJECTION13
70069-027-05Buprenorphine Hydrochloride5 in 1 CARTONINJECTION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-027-05ML - Milliliter70069-0270a167da0-b5af-4b5c-9990-c1b07b0ff20b12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-027BUPRENORPHINE HYDROCHLORIDE INJECTION [SOMERSET THERAPEUTICS, LLC]3Current NDC, 2 package rows20250213_74e40c51-853b-4e7f-b3cb-a27af29e1cbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238129buprenorphine HCl 0.3 MG in 1 ML InjectionPSN74e40c51-853b-4e7f-b3cb-a27af29e1cbf3
2381291 ML buprenorphine 0.3 MG/ML InjectionSCD74e40c51-853b-4e7f-b3cb-a27af29e1cbf3
238129buprenorphine 0.3 MG/ML (as buprenorphine HCl 0.324 MG/ML) InjectionSY74e40c51-853b-4e7f-b3cb-a27af29e1cbf3
238129buprenorphine HCl 0.3 MG per 1 ML InjectionSY74e40c51-853b-4e7f-b3cb-a27af29e1cbf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-027-05700690027055 VIAL in 1 CARTON (70069-027-05) / 1 mL in 1 VIAL5 vial2025-02-11NoNoCurrent