buprenorphine
- Manufacturer
- PAYLESS COMPOUNDERS, LLC
- Effective date
- 2015-10-29
- Label type
- ANIMAL COMPOUNDED DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:48:08
Label at a glance#
Productbuprenorphine
Active ingredientBUPRENORPHINE HYDROCHLORIDE
Label structure1 sections
Label contents#
Full prescribing information#
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BUPRENORPHINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 68654759-f50b-79ef-24c5-544d94fe7d87 | Product name | 3 | 20251114 |
| 08a295bb-88df-4ab0-a120-a75a789a74f1 | Product name | 1 | 20231013 |
| cb89b86a-369e-4204-8910-ae797c503af3 | Product name | 1 | 20230706 |
| ab841ac7-728a-4fc9-be0a-35b96cecbf39 | Product name | 4 | 20230306 |
| 100316cc-94a9-474e-97ad-9b5c6ddec605 | Product name | 5 | 20230125 |
| 539bc5d3-546b-4af6-9c31-058ce6c459d3 | Product name | 2 | 20220210 |
| b871fccd-1de6-4c7f-b9e5-045304641ee6 | Product name | 8 | 20220118 |
| d4880ace-a516-8c47-8dfd-73a4ba5887d7 | Product name | 2 | 20180830 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 31e16ab2-c562-4617-a3e8-ed285320e16e | Product name | 1 | 20180201 |
| 4c23a34c-e8fc-424c-8fa0-ee064ba6eaef | Product name | 1 | 20170706 |
| a5920611-4285-f024-69b9-39ff338b81ea | Product name | 5 | 20170609 |
| 3df867ed-9d48-45cf-bded-1394beaea0b1 | Product name | 3 | 20161206 |
| 973da5bf-b1f9-4de0-81ee-7ca066c98ca4 | Product name | 1 | 20160712 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70022-001-10 | buprenorphine | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE | ACTIVE INGREDIENT | 56W8MW3EN1 | 3 | |
| BUPRENORPHINE | ACTIVE MOIETY | 40D3SCR4GZ | 3 | |
| ANHYDROUS DEXTROSE | INACTIVE INGREDIENT | 5SL0G7R0OK | 3 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | 3 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 3 |
Products#
Every source-derived product name is available through these pages.
- buprenorphine
- BUPRENORPHINE HYDROCHLORIDE
- ANHYDROUS DEXTROSE
- MANNITOL
- WATER
- HYDROCHLORIC ACID
- BENZYL ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70022-001 | 70022-001-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE | 56W8MW3EN1 | ACTIM |
| ANHYDROUS DEXTROSE | 5SL0G7R0OK | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| WATER | 059QF0KO0R | IACT |
| HYDROCHLORIC ACID | QTT17582CB | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ANHYDROUS DEXTROSE | ANHYDROUS DEXTROSE | 5SL0G7R0OK | INJECTION / SUBCUTANEOUS | 7.5 %w/v | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION, CONCENTRATE / INTRAVENOUS | ADJ PH | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, FOR SUSPENSION / ORAL | 7621 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SUSPENSION / INTRAVITREAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / INTRAVESICAL | 157 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SUSPENSION/ DROPS / TOPICAL | 0.3 %w/v | ||
| MANNITOL | MANNITOL | 3OWL53L36A | POWDER, FOR SUSPENSION / ORAL | 7093 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, SOLUTION / SUBMUCOSAL | 2.94 %w/v | ||
| MANNITOL | MANNITOL | 3OWL53L36A | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| ANHYDROUS DEXTROSE | ANHYDROUS DEXTROSE | 5SL0G7R0OK | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 3.9 %w/v | ||
| MANNITOL | MANNITOL | 3OWL53L36A | GRANULE, FOR SUSPENSION / ORAL | 6000 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SUSPENSION / INTRAVENOUS | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / URETERAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | POWDER / INTRAVENOUS | ADJ PH | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, CHEWABLE / ORAL | 3726 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION / INTRAVENOUS | 15400 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, EMULSION / INTRAMUSCULAR | 225 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / TOPICAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION / SOFT TISSUE | ADJ PH | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION / SUBCUTANEOUS | 4.54 %w/v | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, FOR SOLUTION / INTRADERMAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRALESIONAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | CONCENTRATE / ORAL | 2.17 mg/1ml | ||
| MANNITOL | MANNITOL | 3OWL53L36A | CAPSULE, EXTENDED RELEASE / ORAL | 160 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 980.4 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SHAMPOO / TOPICAL | 104 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION / AURICULAR (OTIC) | 0.04 %w/v | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION / INTRAVENOUS | 15200 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | LIQUID / INTRAMUSCULAR | ADJ PH | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, SUSPENSION / INTRAVENOUS | 2.5 %w/v | ||
| MANNITOL | MANNITOL | 3OWL53L36A | LOZENGE / ORAL | 20546 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SUSPENSION / OPHTHALMIC | 9 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | LOTION / TOPICAL | ADJ PH | ||
| MANNITOL | MANNITOL | 3OWL53L36A | GUM, CHEWING / BUCCAL | 891 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRABURSAL | ADJ PH | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SUSPENSION / TOPICAL | 1 %w/w | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | POWDER, FOR SUSPENSION / ORAL | 125 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRAVENOUS | 1620 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / INTRAVASCULAR | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION / PARENTERAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SUSPENSION / INTRALESIONAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.7 %w/w | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | DROPS / NASAL | 10 ml | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION / OPHTHALMIC | 4.7 %w/v | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRACARDIAC | ADJ PH | ||
| ANHYDROUS DEXTROSE | ANHYDROUS DEXTROSE | 5SL0G7R0OK | INJECTION / INTRAVENOUS | 36000 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | GEL / TOPICAL | 10 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTABLE, LIPOSOMAL / INTRAVENOUS | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / NASAL | 91.7 mg/100ml | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRAVITREAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / IRRIGATION | ADJ PH | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 543 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SUSPENSION / ORAL | 100 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / INTRAVASCULAR | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | EMULSION / TOPICAL | ADJ PH |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| buprenorphine hydrochloride | BUPRENORPHINE HYDROCHLORIDE | Advagen Pharma Ltd | 699638dd-3a53-445f-a545-d0e6eabfe1c9 | 2026-07-17 | Warnings, Adverse reactions | BUPRENORPHINE HYDROCHLORIDE |
| Buprenorphine | BUPRENORPHINE | REMEDYREPACK INC. | aa86a438-1ebf-4c08-bf27-38f1e81efb3a | 2026-07-07 | Warnings, Adverse reactions | Buprenorphine |
| buprenorphine hydrochloride | BUPRENORPHINE HYDROCHLORIDE | REMEDYREPACK INC. | 11686845-f5fd-4e96-8a4f-9b132bf48840 | 2026-07-07 | Warnings, Adverse reactions | BUPRENORPHINE HYDROCHLORIDE |
| BUPRENORPHINE | BUPRENORPHINE | Unit Dose Solutions, Inc. | 5578cd5c-c860-6e8a-e063-6394a90a56c7 | 2026-06-30 | Warnings, Adverse reactions | BUPRENORPHINE |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | aa132031-9d12-45b4-81e0-4a5877661379 | 2026-06-29 | Warnings, Adverse reactions | BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | Bryant Ranch Prepack | 655e3e52-03be-496c-978a-5cffc74b2ae4 | 2026-06-29 | Warnings, Adverse reactions | Buprenorphine |
| BUPRENORPHINE | BUPRENORPHINE | Unit Dose Solutions, Inc. | 5479b218-a388-2c3c-e063-6294a90a0e85 | 2026-06-17 | Warnings, Adverse reactions | BUPRENORPHINE |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | 966adb01-71b4-4e0b-bbc6-b83da9987aa2 | 2026-06-16 | Warnings, Adverse reactions | BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | Major Pharmaceuticals | dba586f9-e3f2-4b9c-849b-907c81a5a0ef | 2026-06-16 | Warnings, Adverse reactions | Buprenorphine |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | bc5a7137-9e8f-438e-84d9-bdbf1db12998 | 2026-06-03 | Warnings, Adverse reactions | BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | Rhodes Pharmaceuticals LLC | 2738feae-316e-426f-971c-5f142ac01b60 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | Buprenorphine |
| Buprenorphine | BUPRENORPHINE | Actavis Pharma, Inc. | 03819118-86f6-4329-adaf-4599e7b71f46 | 2026-05-25 | Warnings, Adverse reactions | Buprenorphine |
| Buprenorphine | BUPRENORPHINE | Teva Pharmaceuticals USA, Inc. | 36995ce3-b515-447b-baa9-aa14f84060d8 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | Buprenorphine |
| BUPRENORPHINE | BUPRENORPHINE | Rhodes Pharmaceuticals LLC | da90618a-5621-4b15-bc48-9dcc631418de | 2026-05-04 | Warnings, Adverse reactions | BUPRENORPHINE |
| Buprenorphine | BUPRENORPHINE | INGENUS PHARMACEUTICALS, LLC | 186e3be6-8bc0-4bb9-96f5-429d53632f45 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | Buprenorphine |
| Buprenorphine | BUPRENORPHINE | Aveva Drug Delivery Systems Inc. | 1aae9b13-7431-42ef-8558-14a2325820e6 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | Buprenorphine |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | cd0a90c6-32cc-4114-8573-86ac85503bdf | 2026-04-03 | Warnings, Adverse reactions | BUPRENORPHINE |
| buprenorphine hydrochloride | BUPRENORPHINE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 442831cf-9636-433a-9a12-e9a8cd31f72a | 2026-02-28 | Warnings, Adverse reactions | BUPRENORPHINE HYDROCHLORIDE |
| Buprenorphine | BUPRENORPHINE | Sun Pharmaceutical Industries, Inc. | 9fd1f18f-0b0f-4059-b603-19ecbf0ed63a | 2026-02-11 | Warnings, Adverse reactions | Buprenorphine |
| BUPRENORPHINE | BUPRENORPHINE | A-S Medication Solutions | bfb02ea5-22f2-432e-afc8-f1dbe2ea0614 | 2026-02-06 | Warnings, Adverse reactions | BUPRENORPHINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
