Prescription drug · UNAPPROVED DRUG OTHER
Hydromorphone Hydrochloride NDC 0574-7224
Hydromorphone hydrochloride 3 mg/1 · Suppository · Rectal · Padagis US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0574-7224-06 | 0057472240600574722406 | 6 PACKET in 1 BOX (0574-7224-06) / 1 SUPPOSITORY in 1 PACKETMarketed from Jan 31, 1996 |
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 — 3 mg/1
- Dosage form
- Suppository
- Route
- Rectal
- Labeler
- Padagis US LLCNDC labeler code 0574
- 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 0574-7224_8c369b50-cf2a-4e30-a31c-ccf5f49ab920SPL ID 8c369b50-cf2a-4e30-a31c-ccf5f49ab920SPL set ID 1bfbba46-1979-4797-a29e-d67718131686RxCUI 897749UNII 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.
- NDC on a medical claim
N400574722406followed by a unit qualifier and the quantityPackage 00574-7224-06. 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 suppositories 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 ( 5.1 )] , reserve hydromorphone hydrochloride suppositories 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 suppositories…
Excerpt only. Read the full label for complete information.
About NDC 0574-7224
- What is NDC 0574-7224?
- 0574-7224 is the product NDC for Hydromorphone Hydrochloride, Hydromorphone hydrochloride 3 mg/1 suppository, listed with the FDA by Padagis US LLC. 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?
- Padagis US LLC, NDC labeler code 0574. 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 |