Hydromorphone Hydrochloride
- Product NDC
- 52959-420
- 11-digit product format
- 529590420
- Labeler code
- 52959
- Product ID
- 52959-420_0a9c8629-be18-4f5d-8f19-e96b46d63dbd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydromorphone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- ANDA078439
- Marketing category
- ANDA
- Marketing start
- 2009-12-09
- Marketing end
- 0000-00-00
- Substance
- HYDROMORPHONE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c92985da-a658-b186-e763-2287eda87a86 | Product name | 3 | 20250221 |
| 96c475b3-58c7-b955-d715-0111804a3e50 | Product name | 5 | 20210512 |
| 1dd54659-b775-4fa8-a858-7f0e521fbadc | Product name | 4 | 20200925 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52959-420-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dc0f-f424-e053-dadaa90a57ce | HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52959-420-02 | Hydromorphone Hydrochloride | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52959-420-02 | EA - Each | 52959-420 | 6ba7f20d-9e22-4abb-940a-782d54131b83 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Hydromorphone Hydrochloride | ACTIVE INGREDIENT | L960UP2KRW | HYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
| Hydromorphone | ACTIVE MOIETY | Q812464R06 | HYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
| Anhydrous Lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | HYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
| Lactose Monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | HYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.] | 2 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | HYDROMORPHONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 897696 | HYDROmorphone HCl 2 MG Oral Tablet | PSN | 7c122909-cedb-469a-99de-a44bcd51238d | 2 |
| 897702 | HYDROmorphone HCl 4 MG Oral Tablet | PSN | 7c122909-cedb-469a-99de-a44bcd51238d | 2 |
| 897710 | HYDROmorphone HCl 8 MG Oral Tablet | PSN | 7c122909-cedb-469a-99de-a44bcd51238d | 2 |
| 897696 | hydromorphone hydrochloride 2 MG Oral Tablet | SCD | 7c122909-cedb-469a-99de-a44bcd51238d | 2 |
| 897702 | hydromorphone hydrochloride 4 MG Oral Tablet | SCD | 7c122909-cedb-469a-99de-a44bcd51238d | 2 |
| 897710 | hydromorphone hydrochloride 8 MG Oral Tablet | SCD | 7c122909-cedb-469a-99de-a44bcd51238d | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 52959-420-02 | 52959042002 | 120 in 1 BOTTLE, PLASTIC | Historical |