Buprenorphine HCl

Product NDC
55700-302
11-digit product format
557000302
Labeler code
55700
Product ID
55700-302_d1484609-62f8-4b1e-8864-969b452cfb46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buprenorphine HCl
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA078633
Marketing category
ANDA
Marketing start
2009-10-08
Marketing end
0000-00-00
Substance
BUPRENORPHINE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-302-302025-01-08C16284748780-11030e365-58c9-111a-e063-dadaa90a10e28ca10664-b194-4e28-b40c-91b84fd727fc
55700-302-302024-01-30C16284748780-11030e365-58c9-111a-e063-dadaa90a10e28ca10664-b194-4e28-b40c-91b84fd727fc

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-302-30EA - Each55700-3028730b83d-60d1-417e-b9db-5dd6aa73fdfe12016-06-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-302-305570003023030 TABLET in 1 BOTTLE (55700-302-30) 30 tablet2015-09-230000-00-00NoNoCurrent