NDC 55700-867

BELBUCA

Buprenorphine Hydrochloride

BELBUCA is a Buccal Film, Soluble in the Human Prescription Drug category. It is labeled and distributed by Quality Care Products, Llc. The primary component is Buprenorphine Hydrochloride.

Product ID55700-867_39e10902-3224-4e4b-8fac-51e39aa52b88
NDC55700-867
Product TypeHuman Prescription Drug
Proprietary NameBELBUCA
Generic NameBuprenorphine Hydrochloride
Dosage FormFilm, Soluble
Route of AdministrationBUCCAL
Marketing Start Date2020-06-02
Marketing CategoryNDA / NDA
Application NumberNDA207932
Labeler NameQuality Care Products, LLC
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength450 ug/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 55700-867-60

60 POUCH in 1 BOX (55700-867-60) > 1 FILM, SOLUBLE in 1 POUCH
Marketing Start Date2020-06-02
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "BELBUCA" or generic name "Buprenorphine Hydrochloride"

NDCBrand NameGeneric Name
55700-867BELBUCAbuprenorphine hydrochloride
59385-025BELBUCABELBUCA
59385-021BELBUCABELBUCA
59385-022BELBUCABELBUCA
59385-023BELBUCABELBUCA
59385-024BELBUCABELBUCA
59385-026BELBUCABELBUCA
59385-027BELBUCABELBUCA
12496-0757Buprenexbuprenorphine hydrochloride
50090-2924BuprenorphineBuprenorphine Hydrochloride
0143-9246Buprenorphine HydrochlorideBuprenorphine Hydrochloride
0409-2012Buprenorphine HydrochlorideBuprenorphine Hydrochloride
0517-0725Buprenorphine HydrochlorideBuprenorphine Hydrochloride
21695-515Buprenorphine HydrochlorideBuprenorphine Hydrochloride
35356-556buprenorphine hydrochloridebuprenorphine hydrochloride
42023-179Buprenorphine HydrochlorideBuprenorphine Hydrochloride
50090-1571buprenorphine hydrochloridebuprenorphine hydrochloride
50383-924buprenorphine hydrochloridebuprenorphine hydrochloride
50383-930buprenorphine hydrochloridebuprenorphine hydrochloride
53217-246buprenorphine hydrochloridebuprenorphine hydrochloride
52440-100Probuphinebuprenorphine hydrochloride

Trademark Results [BELBUCA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BELBUCA
BELBUCA
86235385 4946787 Live/Registered
BIODELIVERY SCIENCES INTERNATIONAL, INC.
2014-03-28
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