Opium
- Product NDC
- 64950-258
- 11-digit product format
- 649500258
- Labeler code
- 64950
- Product ID
- 64950-258_b937d1d0-9ed8-4aa3-9e4a-cce02870e7e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- morphine
- Dosage form
- TINCTURE
- Route
- ORAL
- Labeler
- Genus Lifesciences Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2026-05-15
- Substance
- MORPHINE
- Active strength
- 1 g/100mL
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Opium
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MORPHINE | 1 g/100mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 76I7G6D29C |
| Rxcui | 830196 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 89941d4c-522d-cee0-b273-43cfa7ef6d35 | Product name | 4 | 20250516 |
| f15f9e76-db42-8a50-218a-5ef5affa58da | Product name | 4 | 20240216 |
| 944b0689-73f4-6a2f-c654-1180896353c0 | Product name | 4 | 20220210 |
| 67e166c6-23d4-4709-b77d-5ca6182dcae0 | Product name | 1 | 20180830 |
| c573a64c-fe17-2eac-fbcb-788868b4ff6b | Product name | 9 | 20180619 |
| 7c1819cf-69a0-41dc-aeaa-a820729bc959 | Product name | 1 | 20170406 |
| 7a68fc31-10e5-df04-67e0-3a613a2d4d2e | Product name | 5 | 20161114 |
| 175682a8-c657-45a2-9dfb-c565306b03c8 | Product name | 1 | 20160112 |
| b73dadd0-1b4a-4f88-956f-a2be216c8fad | Product name | 1 | 20151123 |
| 4c272b1c-87fc-ebc0-994d-ac28b1e0416e | Product name | 1 | 20140508 |
| 7a537f54-d322-5e54-a3a2-035d3e21c3c6 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64950-258-11 | Opium | 118 mL in 1 BOTTLE | TINCTURE | 118 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 830196 | opium tincture 10 MG (as morphine equivalent) in 1 mL Oral Solution | PSN | 8a77894b-2137-4f46-8dff-5c7b773d4d16 | 1 |
| 830196 | opium tincture 100 MG/ML Oral Solution | SCD | 8a77894b-2137-4f46-8dff-5c7b773d4d16 | 1 |
| 830196 | anhydrous morphine 1 % Oral Solution | SY | 8a77894b-2137-4f46-8dff-5c7b773d4d16 | 1 |
| 830196 | anhydrous morphine 10 MG/ML Oral Solution | SY | 8a77894b-2137-4f46-8dff-5c7b773d4d16 | 1 |
| 830196 | opium tincture 10 % Oral Solution | SY | 8a77894b-2137-4f46-8dff-5c7b773d4d16 | 1 |
| 830196 | opium tincture 10 MG (as morphine equivalent) per 1 ML Oral Solution | SY | 8a77894b-2137-4f46-8dff-5c7b773d4d16 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 64950-258-11 | 64950025811 | 118 mL in 1 BOTTLE (64950-258-11) | 118 ml | 2026-05-15 | No | No | Current |