Prescription drug · NDA AUTHORIZED GENERIC
Hydromorphone Hydrochloride NDC 42858-301
Hydromorphone hydrochloride 2 mg/1 · Tablet · Oral · Rhodes Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42858-301-01 | 42858030101 | 100 TABLET in 1 BOTTLE, PLASTIC (42858-301-01)Marketed from Nov 23, 2009 | |
| 42858-301-25 | 42858030125 | 4 BLISTER PACK in 1 CARTON (42858-301-25) / 25 TABLET in 1 BLISTER PACKMarketed from Nov 23, 2009 |
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 — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rhodes Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 019892
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 42858-301_b786b01b-46f9-4a00-a667-699e813a741bSPL ID b786b01b-46f9-4a00-a667-699e813a741bSPL set ID 37565441-0d95-4743-a695-d7b3326f58a1RxCUI 897657, 897696, 897702, 897710UNII L960UP2KRWUPC 0342858303019
- 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
N442858030101followed by a unit qualifier and the quantityPackage 42858-0301-01. 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 oral solution and hydromorphone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Hydromorphone hydrochloride oral solution and hydromorphone hydrochloride tablets contain hydromorphone, an opioid agonist, and are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, includi…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 019892
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 | Bryant Ranch Prepack | 63629-4284 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 4 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-038 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 2 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-037 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 8 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-039 |
| Dilaudidhydromorphone hydrochloride | Hydromorphone hydrochloride 2 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-122 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 4 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9701 |
| Dilaudidhydromorphone hydrochloride | Hydromorphone hydrochloride 4 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-234 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 4 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-302 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 8 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-303 |
| Dilaudidhydromorphone hydrochloride | Hydromorphone hydrochloride 8 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-338 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 4 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-998 |