FDA.reportPublic FDA data

Buprenorphine and Naloxone

Product NDC
31722-479
11-digit product format
317220479
Labeler code
31722
Product ID
31722-479_fc47f8e4-395a-4030-b9fb-71ba779479bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buprenorphine and naloxone
Dosage form
FILM, SOLUBLE
Route
BUCCAL; SUBLINGUAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA219850
Marketing category
ANDA
Marketing start
2026-05-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219850-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-21
A219850-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 4MG BASE;EQ 1MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-21
A219850-003BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-21
A219850-004BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 12MG BASE;EQ 3MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A219850-001AB
A219850-002AB
A219850-003AB
A219850-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A219850-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-2184e616aacf4f…
2026-09-14 22:38:342026-08A219850-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 4MG BASE;EQ 1MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-2184e616aacf4f…
2026-09-14 22:38:342026-08A219850-003BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-2184e616aacf4f…
2026-09-14 22:38:342026-08A219850-004BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 12MG BASE;EQ 3MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-2184e616aacf4f…
2026-08-18 06:07:402026-07A219850-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A219850-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 4MG BASE;EQ 1MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A219850-003BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-21caaa826d4ba7…
2026-08-18 06:07:402026-07A219850-004BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 12MG BASE;EQ 3MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219850-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219850-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 4MG BASE;EQ 1MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219850-003BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219850-004BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 12MG BASE;EQ 3MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-21011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219850-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219850-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 4MG BASE;EQ 1MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219850-003BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219850-004BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 12MG BASE;EQ 3MG BASEFILM / BUCCAL, SUBLINGUALAB2026-01-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219850-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A219850-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A219850-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A219850-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A219850-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219850-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219850-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219850-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219850-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219850-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219850-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219850-004AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219850-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219850-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219850-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219850-004AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F850569PQRInternal UNII lookup
56W8MW3EN1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1010600Internal RxNorm lookup
1010604Internal RxNorm lookup
1307056Internal RxNorm lookup
1307061Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
221195e4-de08-414c-af08-a611a74789deAvailable on FDA.report

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
31722-479-30Buprenorphine and Naloxone30 in 1 CARTONFILM, SOLUBLE301
31722-479-31Buprenorphine and Naloxone1 in 1 POUCHFILM, SOLUBLE11

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONECamber Pharmaceuticals, Inc.221195e4-de08-414c-af08-a611a74789de2026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219850
application number: ANDA219850
ndc (product): 31722-479

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307061buprenorphine HCl 12 MG / naloxone HCl 3 MG Sublingual FilmPSN221195e4-de08-414c-af08-a611a74789de1
1010600buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual FilmPSN221195e4-de08-414c-af08-a611a74789de1
1307056buprenorphine HCl 4 MG / naloxone HCl 1 MG Sublingual FilmPSN221195e4-de08-414c-af08-a611a74789de1
1010604buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual FilmPSN221195e4-de08-414c-af08-a611a74789de1
1307061buprenorphine 12 MG / naloxone 3 MG Sublingual FilmSCD221195e4-de08-414c-af08-a611a74789de1
1010600buprenorphine 2 MG / naloxone 0.5 MG Sublingual FilmSCD221195e4-de08-414c-af08-a611a74789de1
1307056buprenorphine 4 MG / naloxone 1 MG Sublingual FilmSCD221195e4-de08-414c-af08-a611a74789de1
1010604buprenorphine 8 MG / naloxone 2 MG Sublingual FilmSCD221195e4-de08-414c-af08-a611a74789de1
1307061buprenorphine 12 MG / naloxone 3 MG Sublingual FilmSY221195e4-de08-414c-af08-a611a74789de1
1010600buprenorphine 2 MG / naloxone 0.5 MG Buccal FilmSY221195e4-de08-414c-af08-a611a74789de1
1010600buprenorphine 2 MG / naloxone 0.5 MG Sublingual FilmSY221195e4-de08-414c-af08-a611a74789de1
1307056buprenorphine 4 MG / naloxone 1 MG Buccal FilmSY221195e4-de08-414c-af08-a611a74789de1
1307056buprenorphine 4 MG / naloxone 1 MG Sublingual FilmSY221195e4-de08-414c-af08-a611a74789de1
1010604buprenorphine 8 MG / naloxone 2 MG Buccal FilmSY221195e4-de08-414c-af08-a611a74789de1
1010604buprenorphine 8 MG / naloxone 2 MG Sublingual FilmSY221195e4-de08-414c-af08-a611a74789de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-479-303172204793030 POUCH in 1 CARTON (31722-479-30) / 1 FILM, SOLUBLE in 1 POUCH (31722-479-31) 30 pouch2026-05-01NoNoCurrent
31722-479-31317220479311 in 1 POUCHHistorical