FDA.reportPublic FDA data

Buprenorphine HCl

Product NDC
70518-2014
11-digit product format
705182014
Labeler code
70518
Product ID
70518-2014_498bf1a2-fabc-0a31-e063-6294a90a6e94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buprenorphine HCl
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
REMEDYREPACK INC.
Application
ANDA078633
Marketing category
ANDA
Marketing start
2019-04-12
Substance
BUPRENORPHINE HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Buprenorphine HCl
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii56W8MW3EN1
Rxcui351265

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
68654759-f50b-79ef-24c5-544d94fe7d87Product name320251114
08a295bb-88df-4ab0-a120-a75a789a74f1Product name120231013
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
100316cc-94a9-474e-97ad-9b5c6ddec605Product name520230125
539bc5d3-546b-4af6-9c31-058ce6c459d3Product name220220210
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2014-0Buprenorphine HCl30 in 1 BLISTER PACKTABLET3017
70518-2014-1Buprenorphine HCl60 in 1 BOTTLE, PLASTICTABLET6017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2014-0EA - Each70518-201469339bdd-9555-4c35-87d3-2ab025a9e63712026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2014BUPRENORPHINE HCL TABLET [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 2 package rows20250306_69a647c0-bc09-4ee2-aeb3-ef286caf25e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351265buprenorphine HCl 8 MG Sublingual TabletPSN69a647c0-bc09-4ee2-aeb3-ef286caf25e517
351265buprenorphine 8 MG Sublingual TabletSCD69a647c0-bc09-4ee2-aeb3-ef286caf25e517
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSY69a647c0-bc09-4ee2-aeb3-ef286caf25e517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2014-07051820140030 TABLET in 1 BLISTER PACK (70518-2014-0) 30 tablet2019-04-120000-00-00NoNoCurrent
70518-2014-17051820140160 TABLET in 1 BOTTLE, PLASTIC (70518-2014-1) 60 tablet2021-04-010000-00-00NoNoCurrent