Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
- Product NDC
- 0406-8005
- 11-digit product format
- 004068005
- Labeler code
- 0406
- Product ID
- 0406-8005_bd7bf416-c9b0-42fb-9593-077053c1cdd2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- SpecGx LLC
- Application
- ANDA207000
- Marketing category
- ANDA
- Marketing start
- 2017-12-13
- Substance
- BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
- Active strength
- 2; .5 mg/1; mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA], 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 Hydrochloride and Naloxone Hydrochloride Dihydrate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BUPRENORPHINE HYDROCHLORIDE | 2 mg/1 |
| NALOXONE HYDROCHLORIDE DIHYDRATE | .5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 56W8MW3EN1, 5Q187997EE |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0406-8005-03 | Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 33 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0406-8005-03 | EA - Each | 0406-8005 | 008477fe-7789-44a6-b4f6-9e1cc733b464 | 1 | 2018-09-05 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 351266 | buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual Tablet | PSN | 62abde41-46cb-4e90-a798-23d6531bf9aa | 33 |
| 351267 | buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Tablet | PSN | 62abde41-46cb-4e90-a798-23d6531bf9aa | 33 |
| 351266 | buprenorphine 2 MG / naloxone 0.5 MG Sublingual Tablet | SCD | 62abde41-46cb-4e90-a798-23d6531bf9aa | 33 |
| 351267 | buprenorphine 8 MG / naloxone 2 MG Sublingual Tablet | SCD | 62abde41-46cb-4e90-a798-23d6531bf9aa | 33 |
| 351266 | buprenorphine 2 MG (as buprenorphine HCl) / naloxone 0.5 MG (as naloxone HCl) Sublingual Tablet | SY | 62abde41-46cb-4e90-a798-23d6531bf9aa | 33 |
| 351267 | buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual Tablet | SY | 62abde41-46cb-4e90-a798-23d6531bf9aa | 33 |
| 351266 | buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual Tablet | PSN | 273b79ac-2c62-4407-9cd1-2a2964ef13ba | 2 |
| 351267 | buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Tablet | PSN | 273b79ac-2c62-4407-9cd1-2a2964ef13ba | 2 |
| 351266 | buprenorphine 2 MG / naloxone 0.5 MG Sublingual Tablet | SCD | 273b79ac-2c62-4407-9cd1-2a2964ef13ba | 2 |
| 351267 | buprenorphine 8 MG / naloxone 2 MG Sublingual Tablet | SCD | 273b79ac-2c62-4407-9cd1-2a2964ef13ba | 2 |
| 351266 | buprenorphine 2 MG (as buprenorphine HCl) / naloxone 0.5 MG (as naloxone HCl) Sublingual Tablet | SY | 273b79ac-2c62-4407-9cd1-2a2964ef13ba | 2 |
| 351267 | buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual Tablet | SY | 273b79ac-2c62-4407-9cd1-2a2964ef13ba | 2 |
| 351266 | buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual Tablet | PSN | 4f979409-f9a2-d3a2-e063-6394a90accd0 | 1 |
| 351267 | buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Tablet | PSN | 4f979409-f9a2-d3a2-e063-6394a90accd0 | 1 |
| 351266 | buprenorphine 2 MG / naloxone 0.5 MG Sublingual Tablet | SCD | 4f979409-f9a2-d3a2-e063-6394a90accd0 | 1 |
| 351267 | buprenorphine 8 MG / naloxone 2 MG Sublingual Tablet | SCD | 4f979409-f9a2-d3a2-e063-6394a90accd0 | 1 |
| 351266 | buprenorphine 2 MG (as buprenorphine HCl) / naloxone 0.5 MG (as naloxone HCl) Sublingual Tablet | SY | 4f979409-f9a2-d3a2-e063-6394a90accd0 | 1 |
| 351267 | buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual Tablet | SY | 4f979409-f9a2-d3a2-e063-6394a90accd0 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0406-8005-03 | 00406800503 | 30 TABLET in 1 BOTTLE, PLASTIC (0406-8005-03) | 30 tablet | 2017-12-13 | 0000-00-00 | No | No | Current |