Prescription drug · ANDA
Hydromorphone Hydrochloride NDC 0054-0386
Hydromorphone hydrochloride 1 mg/mL · Solution · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0386-63 | 0005403866300054038663 | 473 mL in 1 BOTTLE (0054-0386-63)Marketed from Mar 1, 2012 |
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 — 1 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074653
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0054-0386_4c3c8198-731d-4136-9222-01063f3364cbSPL ID 4c3c8198-731d-4136-9222-01063f3364cbSPL set ID cc574063-6ede-4da7-82c4-7450c92b229bRxCUI 897657, 897702, 897710UNII L960UP2KRWUPC 0300540386634
- 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
N400054038663followed by a unit qualifier and the quantityPackage 00054-0386-63. 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. 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 Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient ma…
Excerpt only. Read the full label for complete information.
About NDC 0054-0386
- What is NDC 0054-0386?
- 0054-0386 is the product NDC for Hydromorphone Hydrochloride, Hydromorphone hydrochloride 1 mg/mL solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydromorphone Hydrochloride.
- What is the active ingredient?
- Hydromorphone hydrochloride.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydromorphone Hydrochloride?
- 64 other product NDCs are listed under this name. See all Hydromorphone Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydromorphone Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 4 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-998 | 60760-0998-60 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 2 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0641-6254 | 00641-6254-01 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0641-6169 | 00641-6169-10 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 2 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0641-6170 | 00641-6170-10 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride .5 mg/.5mL | InjectionIntramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0641-6206 | 00641-6206-10 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride .2 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0641-6259 | 00641-6259-10 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride .25 mg/.5mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Hospira, Inc. | 0409-1805 | 00409-1805-01 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride .5 mg/.5mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Hospira, Inc. | 0409-4264 | 00409-4264-01 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 5 mg/5mL | SolutionOral | American Health Packaging | 60687-566 | 60687-0566-86 |
| Hydromorphone Hydrochloride | Hydromorphone hydrochloride 2 mg/1 | TabletOral | American Health Packaging | 60687-579 | 60687-0579-01 |