Prescription drug · UNAPPROVED DRUG OTHER
Hydromorphone Hydrochloride NDC 0641-2341
Hydromorphone hydrochloride 2 mg/mL · Injection · Intramuscular, Intravenous, Subcutaneous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-2341-41 | 0064123414100641234141 | 20 VIAL in 1 CARTON (0641-2341-41) / 20 mL in 1 VIAL (0641-2341-39)Marketed from Jan 1, 1972 |
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 — 2 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0641
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0641-2341_29e3211f-1115-45e9-8416-c3dfe01a9916SPL ID 29e3211f-1115-45e9-8416-c3dfe01a9916SPL set ID b325028e-0722-4c8c-9fdb-ab6fb0dc460cRxCUI 897745, 1724276UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400641234141followed by a unit qualifier and the quantityPackage 00641-2341-41. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Hydromorphone Hydrochloride Injection is indicated for the relief of moderate to severe pain such as that due to: surgery, cancer, trauma (soft tissue and bone), biliary colic, myocardial infarction, burns, renal colic.
Excerpt only. Read the full label for complete information.
About NDC 0641-2341
- What is NDC 0641-2341?
- 0641-2341 is the product NDC for Hydromorphone Hydrochloride, Hydromorphone hydrochloride 2 mg/mL injection, 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 0641. 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 |