Hydromorphone Hydrochloride
- Product NDC
- 0527-1353
- 11-digit product format
- 005271353
- Labeler code
- 0527
- Product ID
- 0527-1353_96651dd3-483d-41c4-b179-e7e05470d205
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydromorphone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA077471
- Marketing category
- ANDA
- Marketing start
- 2009-12-09
- Marketing end
- 0000-00-00
- Substance
- HYDROMORPHONE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c92985da-a658-b186-e763-2287eda87a86 | Product name | 3 | 20250221 |
| 96c475b3-58c7-b955-d715-0111804a3e50 | Product name | 5 | 20210512 |
| 1dd54659-b775-4fa8-a858-7f0e521fbadc | Product name | 4 | 20200925 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 897696 | HYDROmorphone HCl 2 MG Oral Tablet | PSN | 88dfac9a-c7ad-01be-e053-2995a90a6d40 | 10 |
| 897696 | hydromorphone hydrochloride 2 MG Oral Tablet | SCD | 88dfac9a-c7ad-01be-e053-2995a90a6d40 | 10 |
| 897696 | HYDROmorphone HCl 2 MG Oral Tablet | PSN | 7c122909-cedb-469a-99de-a44bcd51238d | 2 |
| 897702 | HYDROmorphone HCl 4 MG Oral Tablet | PSN | 7c122909-cedb-469a-99de-a44bcd51238d | 2 |
| 897710 | HYDROmorphone HCl 8 MG Oral Tablet | PSN | 7c122909-cedb-469a-99de-a44bcd51238d | 2 |
| 897696 | hydromorphone hydrochloride 2 MG Oral Tablet | SCD | 7c122909-cedb-469a-99de-a44bcd51238d | 2 |
| 897702 | hydromorphone hydrochloride 4 MG Oral Tablet | SCD | 7c122909-cedb-469a-99de-a44bcd51238d | 2 |
| 897710 | hydromorphone hydrochloride 8 MG Oral Tablet | SCD | 7c122909-cedb-469a-99de-a44bcd51238d | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0527-1353-01 | 00527135301 | 100 TABLET in 1 BOTTLE, PLASTIC (0527-1353-01) | 100 tablet | 2009-12-09 | 0000-00-00 | No | No | Current |