Prescription drug · NDA
Dilaudid (Hydromorphone hydrochloride) NDC 42858-338
Hydromorphone hydrochloride 8 mg/1 · Tablet · Oral · Rhodes Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42858-338-01 | 4285803380142858033801 | 100 TABLET in 1 BOTTLE, PLASTIC (42858-338-01)Marketed from May 15, 2017 |
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)
- Dilaudid
- Generic name (nonproprietary)
- hydromorphone hydrochloride
- Active ingredients
- Hydromorphone hydrochloride — 8 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rhodes Pharmaceuticals LLCNDC labeler code 42858
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019892
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 42858-338_3348b431-907c-4f1d-8a18-e4be2a04df23SPL ID 3348b431-907c-4f1d-8a18-e4be2a04df23SPL set ID d6b40e39-a57e-402c-b4f6-7041e832f837RxCUI 897657, 897658, 897696, 897698, 897702, 897704, 897710, 897712UNII L960UP2KRWUPC 0342858122016
- 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
N442858033801followed by a unit qualifier and the quantityPackage 42858-0338-01. 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)
DILAUDID Oral Solution and DILAUDID 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, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.2) ] , reserve opioid analgesics, including DILAUDID Oral Solution and DILAUDID Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. DILAUDID Oral Solution and DILAUDID Tablets contain hydrom…
Excerpt only. Read the full label for complete information.
About NDC 42858-338
- What is NDC 42858-338?
- 42858-338 is the product NDC for Dilaudid (hydromorphone hydrochloride), Hydromorphone hydrochloride 8 mg/1 tablet, listed with the FDA by Rhodes Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dilaudid (Hydromorphone hydrochloride).
- What is the active ingredient?
- Hydromorphone hydrochloride.
- Who is the labeler?
- Rhodes Pharmaceuticals LLC, NDC labeler code 42858. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dilaudid?
- 6 other product NDCs are listed under this name. See all Dilaudid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dilaudid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dilaudidhydromorphone hydrochloride | Hydromorphone hydrochloride 1 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Fresenius Kabi USA, LLC | 76045-009 | 76045-0009-0676045-0009-11 |
| Dilaudidhydromorphone hydrochloride | Hydromorphone hydrochloride 2 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-122 | 42858-0122-01 |
| Dilaudidhydromorphone hydrochloride | Hydromorphone hydrochloride 4 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-234 | 42858-0234-0142858-0234-50 |
| Dilaudidhydromorphone hydrochloride | Hydromorphone hydrochloride 5 mg/5mL | SolutionOral | Rhodes Pharmaceuticals LLC | 42858-416 | 42858-0416-16 |
| Dilaudidhydromorphone hydrochloride | Hydromorphone hydrochloride 2 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Fresenius Kabi USA, LLC | 76045-010 | 76045-0010-11 |
| Dilaudidhydromorphone hydrochloride | Hydromorphone hydrochloride .2 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Fresenius Kabi USA, LLC | 76045-121 | 76045-0121-11 |
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 8 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-039 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 4 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-998 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 2 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-037 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 4 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-038 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 4 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9701 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 2 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-4284 |
| Dilaudidhydromorphone hydrochloride | Hydromorphone hydrochloride 2 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-122 |
| Dilaudidhydromorphone hydrochloride | Hydromorphone hydrochloride 4 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-234 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 8 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-303 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 2 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-301 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 4 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-302 |