FDA.reportPublic FDA data

buprenorphine buccal film

Product NDC
47781-425
Requested package NDC
47781-425-74
11-digit product format
477810425
Labeler code
47781
Product ID
47781-425_62b1a9fe-2e29-1535-e7d6-327240efa309
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buprenorphine buccal
Dosage form
FILM
Route
BUCCAL
Labeler
Alvogen, Inc.
Application
ANDA211594
Marketing category
ANDA
Marketing start
2021-08-04
Marketing end
0000-00-00
Substance
BUPRENORPHINE HYDROCHLORIDE
Active strength
450 ug/1
Pharmacologic classes
Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog.

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.

Product history page 1 of 6 · 203 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211594-001BUPRENORPHINE HYDROCHLORIDEEQ 0.075MG BASEFILM / BUCCAL2021-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211594-002BUPRENORPHINE HYDROCHLORIDEEQ 0.15MG BASEFILM / BUCCAL2021-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211594-003BUPRENORPHINE HYDROCHLORIDEEQ 0.3MG BASEFILM / BUCCAL2021-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211594-004BUPRENORPHINE HYDROCHLORIDEEQ 0.45MG BASEFILM / BUCCAL2021-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211594-005BUPRENORPHINE HYDROCHLORIDEEQ 0.6MG BASEFILM / BUCCAL2021-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211594-006BUPRENORPHINE HYDROCHLORIDEEQ 0.75MG BASEFILM / BUCCAL2021-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211594-007BUPRENORPHINE HYDROCHLORIDEEQ 0.9MG BASEFILM / BUCCAL2021-08-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211594-001BUPRENORPHINE HYDROCHLORIDEEQ 0.075MG BASEFILM / BUCCAL2021-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211594-002BUPRENORPHINE HYDROCHLORIDEEQ 0.15MG BASEFILM / BUCCAL2021-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211594-003BUPRENORPHINE HYDROCHLORIDEEQ 0.3MG BASEFILM / BUCCAL2021-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211594-004BUPRENORPHINE HYDROCHLORIDEEQ 0.45MG BASEFILM / BUCCAL2021-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211594-005BUPRENORPHINE HYDROCHLORIDEEQ 0.6MG BASEFILM / BUCCAL2021-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211594-006BUPRENORPHINE HYDROCHLORIDEEQ 0.75MG BASEFILM / BUCCAL2021-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211594-007BUPRENORPHINE HYDROCHLORIDEEQ 0.9MG BASEFILM / BUCCAL2021-08-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211594-001BUPRENORPHINE HYDROCHLORIDEEQ 0.075MG BASEFILM / BUCCAL2021-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211594-002BUPRENORPHINE HYDROCHLORIDEEQ 0.15MG BASEFILM / BUCCAL2021-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211594-003BUPRENORPHINE HYDROCHLORIDEEQ 0.3MG BASEFILM / BUCCAL2021-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211594-004BUPRENORPHINE HYDROCHLORIDEEQ 0.45MG BASEFILM / BUCCAL2021-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211594-005BUPRENORPHINE HYDROCHLORIDEEQ 0.6MG BASEFILM / BUCCAL2021-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211594-006BUPRENORPHINE HYDROCHLORIDEEQ 0.75MG BASEFILM / BUCCAL2021-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211594-007BUPRENORPHINE HYDROCHLORIDEEQ 0.9MG BASEFILM / BUCCAL2021-08-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211594-001BUPRENORPHINE HYDROCHLORIDEEQ 0.075MG BASEFILM / BUCCAL2021-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211594-002BUPRENORPHINE HYDROCHLORIDEEQ 0.15MG BASEFILM / BUCCAL2021-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211594-003BUPRENORPHINE HYDROCHLORIDEEQ 0.3MG BASEFILM / BUCCAL2021-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211594-004BUPRENORPHINE HYDROCHLORIDEEQ 0.45MG BASEFILM / BUCCAL2021-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211594-005BUPRENORPHINE HYDROCHLORIDEEQ 0.6MG BASEFILM / BUCCAL2021-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211594-006BUPRENORPHINE HYDROCHLORIDEEQ 0.75MG BASEFILM / BUCCAL2021-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211594-007BUPRENORPHINE HYDROCHLORIDEEQ 0.9MG BASEFILM / BUCCAL2021-08-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211594-001BUPRENORPHINE HYDROCHLORIDEEQ 0.075MG BASEFILM / BUCCAL2021-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211594-002BUPRENORPHINE HYDROCHLORIDEEQ 0.15MG BASEFILM / BUCCAL2021-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211594-003BUPRENORPHINE HYDROCHLORIDEEQ 0.3MG BASEFILM / BUCCAL2021-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211594-004BUPRENORPHINE HYDROCHLORIDEEQ 0.45MG BASEFILM / BUCCAL2021-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211594-005BUPRENORPHINE HYDROCHLORIDEEQ 0.6MG BASEFILM / BUCCAL2021-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211594-006BUPRENORPHINE HYDROCHLORIDEEQ 0.75MG BASEFILM / BUCCAL2021-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211594-007BUPRENORPHINE HYDROCHLORIDEEQ 0.9MG BASEFILM / BUCCAL2021-08-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211594-001BUPRENORPHINE HYDROCHLORIDEEQ 0.075MG BASEFILM / BUCCAL2021-08-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211594-002BUPRENORPHINE HYDROCHLORIDEEQ 0.15MG BASEFILM / BUCCAL2021-08-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211594-003BUPRENORPHINE HYDROCHLORIDEEQ 0.3MG BASEFILM / BUCCAL2021-08-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211594-004BUPRENORPHINE HYDROCHLORIDEEQ 0.45MG BASEFILM / BUCCAL2021-08-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211594-005BUPRENORPHINE HYDROCHLORIDEEQ 0.6MG BASEFILM / BUCCAL2021-08-03d8e5a09893c0…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2021-12-28 21:50 UTC2021-12A211594-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A211594-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A211594-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A211594-004AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A211594-005AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A211594-006AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A211594-007AB1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-425-11EA - Each47781-425dcff8886-5a70-40b1-b474-25220967832e12021-09-07
47781-425-74EA - Each47781-425ec3c0317-0ba2-4db4-88a1-6f704b560dd812021-09-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-425-744778104257460 POUCH in 1 CARTON (47781-425-74) > 1 FILM in 1 POUCH (47781-425-11) 60 pouch2021-08-040000-00-00NoNoCurrent