Hydromorphone Hydrochloride
- Product NDC
- 42858-301
- 11-digit product format
- 428580301
- Labeler code
- 42858
- Product ID
- 42858-301_b786b01b-46f9-4a00-a667-699e813a741b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydromorphone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rhodes Pharmaceuticals LLC
- Application
- NDA019892
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2009-11-23
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydromorphone Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROMORPHONE HYDROCHLORIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L960UP2KRW |
| Rxcui | 897657, 897696, 897702, 897710 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42858-301-01 | Hydromorphone Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 20 |
| 42858-301-25 | Hydromorphone Hydrochloride | 4 in 1 CARTON | TABLET | 4 | | 20 |
| 42858-301-25 | Hydromorphone Hydrochloride | 25 in 1 BLISTER PACK | TABLET | 25 | | 20 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42858-301 | HYDROMORPHONE HYDROCHLORIDE TABLET HYDROMORPHONE HYDROCHLORIDE SOLUTION [RHODES PHARMACEUTICALS L.P.] | 16 | Current NDC, Legacy NDC, 3 package rows | 20240119_37565441-0d95-4743-a695-d7b3326f58a1.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 |
|---|
| 42858-301-01 | 42858030101 | 100 TABLET in 1 BOTTLE, PLASTIC (42858-301-01) | 100 tablet | 2009-11-23 | 0000-00-00 | No | No | Current |
| 42858-301-25 | 42858030125 | 4 BLISTER PACK in 1 CARTON (42858-301-25) / 25 TABLET in 1 BLISTER PACK | 4 blister pack | 2009-11-23 | 0000-00-00 | No | No | Current |