Prescription drug · ANDA
Hydromorphone Hydrochloride NDC 13107-109
Hydromorphone hydrochloride 8 mg/1 · Tablet · Oral · Aurolife Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13107-109-01 | 13107010901 | 100 TABLET in 1 BOTTLE (13107-109-01)Marketed from May 17, 2016 | |
| 13107-109-05 | 13107010905 | 500 TABLET in 1 BOTTLE (13107-109-05)Marketed from May 17, 2016 | |
| 13107-109-20 | 13107010920 | 20 TABLET in 1 BOTTLE (13107-109-20)Marketed from May 17, 2016 | |
| 13107-109-99 | 13107010999 | 1000 TABLET in 1 BOTTLE (13107-109-99)Marketed from May 17, 2016 |
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
- Route
- Oral
- Labeler
- Aurolife Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205814
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 13107-109_1c45740c-5fb6-4cf7-81b9-0865717334e5SPL ID 1c45740c-5fb6-4cf7-81b9-0865717334e5SPL set ID f778dfab-e109-428e-b1b7-4dfb1b8293e4RxCUI 897696, 897702, 897710UNII 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
N413107010901followed by a unit qualifier and the quantityPackage 13107-0109-01. 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 Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.2 )], reserve Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia Hydromorphone Hydrochloride Tablets contain hydromorphone,…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205814
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 2 mg/1 | TabletOral | Aurolife Pharma, LLC | 13107-107 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 4 mg/1 | TabletOral | Aurolife Pharma, LLC | 13107-108 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 4 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0723 |