Home NDC 0228-3153-03 Buprenorphine
Product NDC 0228-3153
Requested package NDC 0228-3153-03
11-digit product format 002283153
Labeler code 0228
Product ID 0228-3153_db0d877f-2f4d-4cf9-b463-6badf66037a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Buprenorphine
Dosage form TABLET
Route SUBLINGUAL
Labeler Actavis Pharma, Inc.
Application ANDA090819
Marketing category ANDA
Marketing start 2015-02-19
Substance BUPRENORPHINE HYDROCHLORIDE
Active strength 8 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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090819-001 BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 A090819-002 BUPRENORPHINE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090819-001 BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE TABLET / SUBLINGUAL AB 2015-02-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090819-002 BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE TABLET / SUBLINGUAL AB 2015-02-19 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPRENORPHINE HYDROCHLORIDE 8 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 56W8MW3EN1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 351264 Internal RxNorm lookup 351265 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0228-3153-03 Buprenorphine 30 in 1 BOTTLE TABLET 30 34
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BUPRENORPHINE HYDROCHLORIDE ACTIVE INGREDIENT 56W8MW3EN1 BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] 3 BUPRENORPHINE ACTIVE MOIETY 40D3SCR4GZ BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] 3 MANNITOL INACTIVE INGREDIENT 3OWL53L36A BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] 3 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0228-3153 BUPRENORPHINE TABLET [ACTAVIS PHARMA, INC.] 32 Current NDC, Legacy NDC, 1 package rows 20250416_03819118-86f6-4329-adaf-4599e7b71f46.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0228-3153-03 00228315303 30 TABLET in 1 BOTTLE (0228-3153-03) 30 tablet 2015-04-10 0000-00-00 No No Current