Prescription drug · ANDA
hydromorphone hydrochloride NDC 0574-0294
Hydromorphone hydrochloride 12 mg/1 · Tablet, Extended release · Oral · Padagis US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0574-0294-01 | 00574029401 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0574-0294-01)Marketed from May 22, 2015 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- hydromorphone hydrochloride
- Generic name (nonproprietary)
- hydromorphone hydrochloride
- Active ingredients
- Hydromorphone hydrochloride — 12 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Padagis US LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204278
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0574-0294_8b576b81-17fc-4251-acc3-6e1b9e18030cSPL ID 8b576b81-17fc-4251-acc3-6e1b9e18030cSPL set ID 780a2616-0392-4715-bc50-71799bea1957RxCUI 902729, 902736, 902741, 1306898UNII L960UP2KRW
- Pharmacologic class
- Opioid Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400574029401followed by a unit qualifier and the quantityPackage 00574-0294-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Hydromorphone hydrochloride extended-release tablets are indicated in opioid-tolerant patients for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use • Because of the risks of addiction, abuse, misuse, overdose, and …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204278
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| hydromorphone hydrochloride | Hydromorphone hydrochloride 8 mg/1 | Tablet, Extended releaseOral | Padagis US LLC | 0574-0293 |
| hydromorphone hydrochloride | Hydromorphone hydrochloride 16 mg/1 | Tablet, Extended releaseOral | Padagis US LLC | 0574-0295 |
| hydromorphone hydrochloride | Hydromorphone hydrochloride 32 mg/1 | Tablet, Extended releaseOral | Padagis US LLC | 0574-0297 |