HYDROMORPHONE HYDROCHLORIDE
- Product NDC
- 13107-107
- 11-digit product format
- 131070107
- Labeler code
- 13107
- Product ID
- 13107-107_1c45740c-5fb6-4cf7-81b9-0865717334e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROMORPHONE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurolife Pharma, LLC
- Application
- ANDA205814
- Marketing category
- ANDA
- Marketing start
- 2016-05-17
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HYDROMORPHONE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROMORPHONE HYDROCHLORIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L960UP2KRW |
| Rxcui | 897696, 897702, 897710 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13107-107-01 | HYDROMORPHONE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
| 13107-107-05 | HYDROMORPHONE HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET | 500 | | 7 |
| 13107-107-20 | HYDROMORPHONE HYDROCHLORIDE | 20 in 1 BOTTLE | TABLET | 20 | | 7 |
| 13107-107-99 | HYDROMORPHONE HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET | 1000 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13107-107 | HYDROMORPHONE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC] | 7 | Current NDC, Legacy NDC, 4 package rows | 20240706_f778dfab-e109-428e-b1b7-4dfb1b8293e4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 13107-107-01 | 13107010701 | 100 TABLET in 1 BOTTLE (13107-107-01) | 100 tablet | 2016-05-17 | 0000-00-00 | No | No | Current |
| 13107-107-05 | 13107010705 | 500 TABLET in 1 BOTTLE (13107-107-05) | 500 tablet | 2016-05-17 | 0000-00-00 | No | No | Current |
| 13107-107-20 | 13107010720 | 20 TABLET in 1 BOTTLE (13107-107-20) | 20 tablet | 2016-05-17 | 0000-00-00 | No | No | Current |
| 13107-107-99 | 13107010799 | 1000 TABLET in 1 BOTTLE (13107-107-99) | 1000 tablet | 2016-05-17 | 0000-00-00 | No | No | Current |