FDA.reportPublic FDA data

Buprenorphine and Naloxone

Product NDC
0378-8765
11-digit product format
003788765
Labeler code
0378
Product ID
0378-8765_008d89ec-5bd7-46d9-bc94-9cdc7405f95d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buprenorphine and Naloxone
Dosage form
FILM
Route
BUCCAL; SUBLINGUAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA211785
Marketing category
ANDA
Marketing start
2020-04-17
Substance
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
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 DIHYDRATE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii56W8MW3EN1, 5Q187997EE
Rxcui1010600, 1010604, 1307056, 1307061

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
31e16ab2-c562-4617-a3e8-ed285320e16eProduct name120180201
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-8765-16Buprenorphine and Naloxone1 in 1 POUCHFILM112
0378-8765-93Buprenorphine and Naloxone30 in 1 CARTONFILM3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-8765-16EA - Each0378-8765ad31cec3-e4e6-4186-9b80-385f396b5b7212020-05-08
0378-8765-93EA - Each0378-8765d7283375-1f4c-48dd-bc33-bd107f2f689012020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-8765BUPRENORPHINE AND NALOXONE FILM [MYLAN PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 2 package rows20240418_557d8d4d-8751-431c-b18e-9d5cf23fc579.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307061buprenorphine HCl 12 MG / naloxone HCl 3 MG Sublingual FilmPSN557d8d4d-8751-431c-b18e-9d5cf23fc57912
1010600buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual FilmPSN557d8d4d-8751-431c-b18e-9d5cf23fc57912
1307056buprenorphine HCl 4 MG / naloxone HCl 1 MG Sublingual FilmPSN557d8d4d-8751-431c-b18e-9d5cf23fc57912
1010604buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual FilmPSN557d8d4d-8751-431c-b18e-9d5cf23fc57912
1307061buprenorphine 12 MG / naloxone 3 MG Sublingual FilmSCD557d8d4d-8751-431c-b18e-9d5cf23fc57912
1010600buprenorphine 2 MG / naloxone 0.5 MG Sublingual FilmSCD557d8d4d-8751-431c-b18e-9d5cf23fc57912
1307056buprenorphine 4 MG / naloxone 1 MG Sublingual FilmSCD557d8d4d-8751-431c-b18e-9d5cf23fc57912
1010604buprenorphine 8 MG / naloxone 2 MG Sublingual FilmSCD557d8d4d-8751-431c-b18e-9d5cf23fc57912
1307061buprenorphine 12 MG / naloxone 3 MG Sublingual FilmSY557d8d4d-8751-431c-b18e-9d5cf23fc57912
1010600buprenorphine 2 MG / naloxone 0.5 MG Buccal FilmSY557d8d4d-8751-431c-b18e-9d5cf23fc57912
1010600buprenorphine 2 MG / naloxone 0.5 MG Sublingual FilmSY557d8d4d-8751-431c-b18e-9d5cf23fc57912
1307056buprenorphine 4 MG / naloxone 1 MG Buccal FilmSY557d8d4d-8751-431c-b18e-9d5cf23fc57912
1307056buprenorphine 4 MG / naloxone 1 MG Sublingual FilmSY557d8d4d-8751-431c-b18e-9d5cf23fc57912
1010604buprenorphine 8 MG / naloxone 2 MG Buccal FilmSY557d8d4d-8751-431c-b18e-9d5cf23fc57912
1010604buprenorphine 8 MG / naloxone 2 MG Sublingual FilmSY557d8d4d-8751-431c-b18e-9d5cf23fc57912
1010600buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual FilmPSN300ae3d0-464c-d0be-e063-6294a90a7f9d4
1010600buprenorphine 2 MG / naloxone 0.5 MG Sublingual FilmSCD300ae3d0-464c-d0be-e063-6294a90a7f9d4
1010600buprenorphine 2 MG / naloxone 0.5 MG Buccal FilmSY300ae3d0-464c-d0be-e063-6294a90a7f9d4
1010600buprenorphine 2 MG / naloxone 0.5 MG Sublingual FilmSY300ae3d0-464c-d0be-e063-6294a90a7f9d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-8765-16003788765161 in 1 POUCHHistorical
0378-8765-930037887659330 POUCH in 1 CARTON (0378-8765-93) / 1 FILM in 1 POUCH (0378-8765-16) 30 pouch2020-04-170000-00-00NoNoCurrent