Hydromorphone Hydrochloride
- Product NDC
- 0406-3249
- 11-digit product format
- 004063249
- Labeler code
- 0406
- Product ID
- 0406-3249_8c16f6cf-c3d2-458c-9cd1-4fddd7c473a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydromorphone hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- ANDA076855
- Marketing category
- ANDA
- Marketing start
- 2004-12-23
- 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
- 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 | 8 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 |
|---|
| 0406-3249-01 | Hydromorphone Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 28 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROMORPHONE HYDROCHLORIDE | ACTIVE INGREDIENT | L960UP2KRW | HYDROMORPHONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] | 10 | |
| HYDROMORPHONE | ACTIVE MOIETY | Q812464R06 | HYDROMORPHONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] | 10 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDROMORPHONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] | 10 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | HYDROMORPHONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] | 10 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROMORPHONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] | 10 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | HYDROMORPHONE HYDROCHLORIDE TABLET [MALLINCKRODT, INC.] | 10 | |
| HYDROMORPHONE HYDROCHLORIDE | ACTIVE INGREDIENT | L960UP2KRW | HYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| HYDROMORPHONE | ACTIVE MOIETY | Q812464R06 | HYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | HYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | HYDROMORPHONE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0406-3249 | HYDROMORPHONE HYDROCHLORIDE TABLET [SPECGX LLC] | 28 | Current NDC, Legacy NDC, 1 package rows | 20250412_4c5c1cc8-c42b-46e3-ad68-8e22f57101f2.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 |
|---|
| 0406-3249-01 | 00406324901 | 100 TABLET in 1 BOTTLE (0406-3249-01) | 100 tablet | 2004-12-23 | 0000-00-00 | No | No | Current |