OPIUM
- Product NDC
- 10191-1086
- 11-digit product format
- 101911086
- Labeler code
- 10191
- Product ID
- 10191-1086_1a61a75c-19ff-462e-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Raw Opium Gum
- Dosage form
- PELLET
- Route
- SUBLINGUAL
- Labeler
- Remedy Makers
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2015-07-08
- Marketing end
- 0000-00-00
- Substance
- OPIUM
- Active strength
- 30 [hp_X]/1
- DEA schedule
- CII
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 10191-1086 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 10191-1086 | 10191-1086-2 | I | Inactivated by FDA | 2026-08-03 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10191-1086-2 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-71ec-f424-e053-dadaa90a57ce | 1a61a75c-19fe-462e-e054-00144ff8d46c |
| 10191-1086-2 | 2023-03-07 | C162847 | 48780-1 | 9d75b9d0-71ec-f424-e053-dadaa90a57ce | 1a61a75c-19fe-462e-e054-00144ff8d46c |
| 10191-1086-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-71ec-f424-e053-dadaa90a57ce | 1a61a75c-19fe-462e-e054-00144ff8d46c |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10191-1086-2 | OPIUM | 165 in 1 VIAL, GLASS | PELLET | 165 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| OPIUM | ACTIVE INGREDIENT | 37M3MZ001L | OPIUM (RAW OPIUM GUM) PELLET [REMEDY MAKERS] | 1 | |
| OPIUM | ACTIVE MOIETY | 37M3MZ001L | OPIUM (RAW OPIUM GUM) PELLET [REMEDY MAKERS] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | OPIUM (RAW OPIUM GUM) PELLET [REMEDY MAKERS] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | OPIUM (RAW OPIUM GUM) PELLET [REMEDY MAKERS] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10191-1086 | OPIUM (RAW OPIUM GUM) PELLET [REMEDY MAKERS] | 2 | Legacy NDC, 1 package rows | 20230309_1a61a75c-19fe-462e-e054-00144ff8d46c.zip |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 10191-1086-2 | 10191108602 | 165 in 1 VIAL, GLASS | Historical |