FDA.reportPublic FDA data

Buprenorphine and Naloxone

Product NDC
67296-2228
11-digit product format
672962228
Labeler code
67296
Product ID
67296-2228_5005a983-ae58-d64e-e063-6294a90a2615
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buprenorphine and naloxone
Dosage form
FILM
Route
BUCCAL; SUBLINGUAL
Labeler
Redpharm Drug
Application
ANDA212756
Marketing category
ANDA
Marketing start
2023-08-29
Substance
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Active strength
2; .5 mg/1; mg/1
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA], 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 and Naloxone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 mg/1
NALOXONE HYDROCHLORIDE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii56W8MW3EN1, F850569PQR
Rxcui1010600

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
68654759-f50b-79ef-24c5-544d94fe7d87Product name320251114
c955d208-c333-9bd7-be34-d7e12986d44eProduct name620250626
e5f98bfa-66d5-4c3a-b22d-9543d3bee304Product name120250204
caa6391e-3db3-c912-335f-61b5fc00aa12Product name920240110
08a295bb-88df-4ab0-a120-a75a789a74f1Product name120231013
65a3bc34-04ff-4cf1-aad9-c7d92a062f6dProduct name120231003
e951cdf3-f269-4d97-a7d5-c1c3d7283a7dProduct name320230313
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
100316cc-94a9-474e-97ad-9b5c6ddec605Product name520230125
f327b80c-8fa2-404b-838a-df3eec141cf2Product name120221212
d4aa2fcf-79c3-4b5f-a00e-1a8e26e00119Product name120220511
539bc5d3-546b-4af6-9c31-058ce6c459d3Product name220220210
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
43b1efe2-1425-4b3e-b3a2-57d40f8478b9Product name120211026
31e16ab2-c562-4617-a3e8-ed285320e16eProduct name120180201
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
a5920611-4285-f024-69b9-39ff338b81eaProduct name520170609
0b8c7273-1da3-495f-909a-7cf1e96d2361Product name120161212
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4Product name120160712
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-2228-1Buprenorphine and Naloxone6 in 1 CARTONFILM61
67296-2228-1Buprenorphine and Naloxone1 in 1 POUCHFILM11
67296-2228-3Buprenorphine and Naloxone1 in 1 POUCHFILM11
67296-2228-3Buprenorphine and Naloxone30 in 1 CARTONFILM301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010600buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual FilmPSN5005a6c8-9a3b-a99a-e063-6294a90aac131
1010600buprenorphine 2 MG / naloxone 0.5 MG Sublingual FilmSCD5005a6c8-9a3b-a99a-e063-6294a90aac131
1010600buprenorphine 2 MG / naloxone 0.5 MG Buccal FilmSY5005a6c8-9a3b-a99a-e063-6294a90aac131
1010600buprenorphine 2 MG / naloxone 0.5 MG Sublingual FilmSY5005a6c8-9a3b-a99a-e063-6294a90aac131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2228-1672962228016 POUCH in 1 CARTON (67296-2228-1) / 1 FILM in 1 POUCH6 pouch2024-08-08NoNoCurrent
67296-2228-36729622280330 POUCH in 1 CARTON (67296-2228-3) / 1 FILM in 1 POUCH30 pouch2024-08-08NoNoCurrent