Prescription drug · ANDA
hydromorphone hydrochloride NDC 31722-119
Hydromorphone hydrochloride 8 mg/1 · Tablet, Extended release · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-119-01 | 31722011901 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-119-01)Marketed from Sep 24, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 8 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212133
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 31722-119_8b32d26f-fcb6-43f3-bfd3-8769e9ca6138SPL ID 8b32d26f-fcb6-43f3-bfd3-8769e9ca6138SPL set ID c33e6320-4206-4b69-8cac-ebfc2351b8f2RxCUI 902729, 902736, 902741, 1306898UNII L960UP2KRWUPC 0331722120012, 0331722119016, 0331722121019, 0331722122016
- 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
N431722011901followed by a unit qualifier and the quantityPackage 31722-0119-01. 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 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 death, which can occur at any …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212133
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 12 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-120 |
| hydromorphone hydrochloride | Hydromorphone hydrochloride 16 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-121 |
| hydromorphone hydrochloride | Hydromorphone hydrochloride 32 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-122 |
| hydromorphone hydrochloride | Hydromorphone hydrochloride 16 mg/1 | Tablet, Extended releaseOral | XLCare Pharmaceuticals, Inc. | 72865-170 |
| hydromorphone hydrochloride | Hydromorphone hydrochloride 8 mg/1 | Tablet, Extended releaseOral | XLCare Pharmaceuticals, Inc. | 72865-168 |
| hydromorphone hydrochloride | Hydromorphone hydrochloride 12 mg/1 | Tablet, Extended releaseOral | XLCare Pharmaceuticals, Inc. | 72865-169 |
| hydromorphone hydrochloride | Hydromorphone hydrochloride 32 mg/1 | Tablet, Extended releaseOral | XLCare Pharmaceuticals, Inc. | 72865-171 |