hydromorphone hydrochloride
- Product NDC
- 0574-0293
- 11-digit product format
- 005740293
- Labeler code
- 0574
- Product ID
- 0574-0293_8b576b81-17fc-4251-acc3-6e1b9e18030c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydromorphone hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Padagis US LLC
- Application
- ANDA204278
- Marketing category
- ANDA
- Marketing start
- 2015-05-22
- Substance
- HYDROMORPHONE HYDROCHLORIDE
- Active strength
- 8 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 | 8 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L960UP2KRW |
| Rxcui | 902729, 902736, 902741, 1306898 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0574-0293-01 | hydromorphone hydrochloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 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, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
| HYDROMORPHONE | ACTIVE MOIETY | Q812464R06 | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
| AMMONIO METHACRYLATE COPOLYMER TYPE A | INACTIVE INGREDIENT | 8GQS4E66YY | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
| ETHYLCELLULOSE (100 MPA.S) | INACTIVE INGREDIENT | 47MLB0F1MV | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0574-0293 | HYDROMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE [PADAGIS US LLC] | 17 | Current NDC, Legacy NDC, 1 package rows | 20240116_780a2616-0392-4715-bc50-71799bea1957.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0574-0293-01 | 00574029301 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0574-0293-01) | 2015-05-22 | 0000-00-00 | No | No | Current |