FDA.reportPublic FDA data

Buprenorphine HCl

Product NDC
31722-870
11-digit product format
317220870
Labeler code
31722
Product ID
31722-870_80bd7b21-6679-4dbb-84dd-f755c7a90166
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buprenorphine HCl
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA219401
Marketing category
ANDA
Marketing start
2026-01-12
Substance
BUPRENORPHINE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219401-001BUPRENORPHINE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2025-12-18
A219401-002BUPRENORPHINE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2025-12-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A219401-001AB
A219401-002AB

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
2026-08-18 06:07:402026-07A219401-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2025-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07A219401-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2025-12-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219401-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2025-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219401-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2025-12-18011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219401-001BUPRENORPHINE HYDROCHLORIDEEQ 2MG BASETABLET / SUBLINGUALAB2025-12-18a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219401-002BUPRENORPHINE HYDROCHLORIDEEQ 8MG BASETABLET / SUBLINGUALAB2025-12-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A219401-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219401-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219401-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219401-002AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219401-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219401-002AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Buprenorphine HCl
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
351264Internal RxNorm lookup
351265Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b52cea0e-688f-4beb-bf7d-f228b81dbd23Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
68654759-f50b-79ef-24c5-544d94fe7d87Product name320251114
08a295bb-88df-4ab0-a120-a75a789a74f1Product name120231013
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
100316cc-94a9-474e-97ad-9b5c6ddec605Product name520230125
539bc5d3-546b-4af6-9c31-058ce6c459d3Product name220220210
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
31e16ab2-c562-4617-a3e8-ed285320e16eProduct name120180201
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
a5920611-4285-f024-69b9-39ff338b81eaProduct name520170609
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4Product name120160712

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-870-30Buprenorphine HCl30 in 1 BOTTLETABLET301

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 HClBUPRENORPHINE HCLCamber Pharmaceuticals, Inc.b52cea0e-688f-4beb-bf7d-f228b81dbd232026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219401
application number: ANDA219401
ndc (product): 31722-870

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351264buprenorphine HCl 2 MG Sublingual TabletPSNb52cea0e-688f-4beb-bf7d-f228b81dbd231
351265buprenorphine HCl 8 MG Sublingual TabletPSNb52cea0e-688f-4beb-bf7d-f228b81dbd231
351264buprenorphine 2 MG Sublingual TabletSCDb52cea0e-688f-4beb-bf7d-f228b81dbd231
351265buprenorphine 8 MG Sublingual TabletSCDb52cea0e-688f-4beb-bf7d-f228b81dbd231
351264buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual TabletSYb52cea0e-688f-4beb-bf7d-f228b81dbd231
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSYb52cea0e-688f-4beb-bf7d-f228b81dbd231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-870-303172208703030 TABLET in 1 BOTTLE (31722-870-30) 30 tablet2026-01-12NoNoCurrent