Hydromorphone Hydrochloride
- Product NDC
- 0054-0264
- 11-digit product format
- 000540264
- Labeler code
- 0054
- Product ID
- 0054-0264_6d31049c-2cef-4f8e-9e8b-2fd65c1e0b33
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydromorphone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA074597
- Marketing category
- ANDA
- Marketing start
- 2009-07-29
- Marketing end
- 0000-00-00
- Substance
- HYDROMORPHONE HYDROCHLORIDE
- Active strength
- 4 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0264-24 | Hydromorphone Hydrochloride | 10 in 1 CONTAINER | TABLET | 10 | | 20 |
| 0054-0264-24 | Hydromorphone Hydrochloride | 10 in 1 CARTON | TABLET | 10 | | 20 |
| 0054-0264-25 | Hydromorphone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROMORPHONE HYDROCHLORIDE | ACTIVE INGREDIENT | L960UP2KRW | HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 9 | |
| HYDROMORPHONE | ACTIVE MOIETY | Q812464R06 | HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 9 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 9 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 9 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 9 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 9 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 9 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 9 | |
| RASPBERRY | INACTIVE INGREDIENT | 4N14V5R27W | HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 9 | |
| SACCHARIN SODIUM ANHYDROUS | INACTIVE INGREDIENT | I4807BK602 | HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 9 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 9 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0264 | HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 19 | Legacy NDC, 3 package rows | 20240308_cc574063-6ede-4da7-82c4-7450c92b229b.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 |
|---|
| 0054-0264-24 | 00054026424 | 10 CONTAINER in 1 CARTON (0054-0264-24) > 10 TABLET in 1 CONTAINER | 10 container | 2009-07-29 | 0000-00-00 | No | No | Current |
| 0054-0264-25 | 00054026425 | 100 TABLET in 1 BOTTLE (0054-0264-25) | 100 tablet | 2009-07-29 | 0000-00-00 | No | No | Current |