SUBLOCADE
- Product NDC
- 12496-0100
- 11-digit product format
- 124960100
- Labeler code
- 12496
- Product ID
- 12496-0100_a5971cb4-0e84-4bc6-a2ff-bbd668f2dbec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- buprenorphine
- Dosage form
- SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Indivior Inc.
- Application
- NDA209819
- Marketing category
- NDA
- Marketing start
- 2018-02-26
- Substance
- BUPRENORPHINE
- Active strength
- 100 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SUBLOCADE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUPRENORPHINE | 100 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 40D3SCR4GZ |
| Rxcui | 1996184, 1996189, 1996192, 1996193 |
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 |
| 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 |
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 12496-0100-1 | SUBLOCADE | 1 in 1 CARTON | SOLUTION | 1 | 42 | |
| 12496-0100-2 | SUBLOCADE | 1 in 1 POUCH | SOLUTION | 1 | 42 | |
| 12496-0100-5 | SUBLOCADE | 1 in 1 SYRINGE | SOLUTION | 1 | 42 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 12496-0100-1 | ML - Milliliter | 12496-0100 | 98083f46-e176-4dfa-ae03-77e1983e2fa1 | 1 | 2018-01-12 |
| 12496-0100-2 | ML - Milliliter | 12496-0100 | 58419e46-1521-42e1-9f62-5a37c7de0c90 | 1 | 2018-03-08 |
| 12496-0100-5 | ML - Milliliter | 12496-0100 | ed446cab-fe1d-49b3-b402-087b5f2cbaf1 | 1 | 2019-01-24 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 12496-0100 | SUBLOCADE (BUPRENORPHINE) SOLUTION [INDIVIOR INC.] | 38 | Current NDC, Legacy NDC, 3 package rows | 20250309_6189fb21-9432-45f8-8481-0bfaf3ccde95.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1996184 | buprenorphine 100 MG in 0.5 mL Prefilled Syringe | PSN | 6189fb21-9432-45f8-8481-0bfaf3ccde95 | 42 |
| 1996192 | buprenorphine 300 MG in 1.5 mL Prefilled Syringe | PSN | 6189fb21-9432-45f8-8481-0bfaf3ccde95 | 42 |
| 1996189 | SUBLOCADE 100 MG in 0.5 mL Prefilled Syringe | PSN | 6189fb21-9432-45f8-8481-0bfaf3ccde95 | 42 |
| 1996193 | SUBLOCADE 300 MG in 1.5 mL Prefilled Syringe | PSN | 6189fb21-9432-45f8-8481-0bfaf3ccde95 | 42 |
| 1996189 | 0.5 ML buprenorphine 200 MG/ML Prefilled Syringe [Sublocade] | SBD | 6189fb21-9432-45f8-8481-0bfaf3ccde95 | 42 |
| 1996193 | 1.5 ML buprenorphine 200 MG/ML Prefilled Syringe [Sublocade] | SBD | 6189fb21-9432-45f8-8481-0bfaf3ccde95 | 42 |
| 1996184 | 0.5 ML buprenorphine 200 MG/ML Prefilled Syringe | SCD | 6189fb21-9432-45f8-8481-0bfaf3ccde95 | 42 |
| 1996192 | 1.5 ML buprenorphine 200 MG/ML Prefilled Syringe | SCD | 6189fb21-9432-45f8-8481-0bfaf3ccde95 | 42 |
| 1996189 | 0.5 ML Sublocade 200 MG/ML Prefilled Syringe | SY | 6189fb21-9432-45f8-8481-0bfaf3ccde95 | 42 |
| 1996193 | 1.5 ML Sublocade 200 MG/ML Prefilled Syringe | SY | 6189fb21-9432-45f8-8481-0bfaf3ccde95 | 42 |
| 1996184 | buprenorphine 100 MG per 0.5 ML Prefilled Syringe | SY | 6189fb21-9432-45f8-8481-0bfaf3ccde95 | 42 |
| 1996192 | buprenorphine 300 MG per 1.5 ML Prefilled Syringe | SY | 6189fb21-9432-45f8-8481-0bfaf3ccde95 | 42 |
| 1996189 | Sublocade 100 MG per 0.5 ML Prefilled Syringe | SY | 6189fb21-9432-45f8-8481-0bfaf3ccde95 | 42 |
| 1996193 | Sublocade 300 MG per 1.5 ML Prefilled Syringe | SY | 6189fb21-9432-45f8-8481-0bfaf3ccde95 | 42 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 12496-0100-1 | 12496010001 | 1 POUCH in 1 CARTON (12496-0100-1) / 1 SYRINGE in 1 POUCH (12496-0100-2) / 1 SOLUTION in 1 SYRINGE (12496-0100-5) | 1 pouch | 2018-02-26 | 0000-00-00 | No | No | Current |
| 12496-0100-2 | 12496010002 | 1 in 1 POUCH | Historical | |||||
| 12496-0100-5 | 12496010005 | 1 in 1 SYRINGE | Historical |