FDA.reportPublic FDA data

Buprenorphine

Product NDC
60687-481
11-digit product format
606870481
Labeler code
60687
Product ID
60687-481_2a815afd-4f27-120b-e063-6394a90a82a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buprenorphine
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
American Health Packaging
Application
ANDA207276
Marketing category
ANDA
Marketing start
2020-02-06
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Buprenorphine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii56W8MW3EN1
Rxcui351264, 351265

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
60687-481-11Buprenorphine1 in 1 BLISTER PACKTABLET15
60687-481-21Buprenorphine30 in 1 BOX, UNIT-DOSETABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-481-11EA - Each60687-4818b549918-6985-423c-939b-8ef1a1671f1d12020-02-13
60687-481-21EA - Each60687-481a5bd1f57-5898-4f5b-b9fc-9ce62ebac01612020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-481BUPRENORPHINE TABLET [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20250104_8d38f7aa-da0b-40ad-b0d1-4284c71042ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351264buprenorphine HCl 2 MG Sublingual TabletPSN8d38f7aa-da0b-40ad-b0d1-4284c71042ed5
351265buprenorphine HCl 8 MG Sublingual TabletPSN8d38f7aa-da0b-40ad-b0d1-4284c71042ed5
351264buprenorphine 2 MG Sublingual TabletSCD8d38f7aa-da0b-40ad-b0d1-4284c71042ed5
351265buprenorphine 8 MG Sublingual TabletSCD8d38f7aa-da0b-40ad-b0d1-4284c71042ed5
351264buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual TabletSY8d38f7aa-da0b-40ad-b0d1-4284c71042ed5
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSY8d38f7aa-da0b-40ad-b0d1-4284c71042ed5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-481-11606870481111 in 1 BLISTER PACKHistorical
60687-481-216068704812130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-481-21) / 1 TABLET in 1 BLISTER PACK (60687-481-11) 30 blister pack2020-02-060000-00-00NoNoCurrent