Prescription drug · ANDA
apomorphine hydrocloride (Apomorphine hydrochloride) NDC 52817-720
Apomorphine hydrochloride 30 mg/3mL · Injection · Subcutaneous · TruPharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52817-720-05 | 5281707200552817072005 | 5 CARTRIDGE in 1 CARTON (52817-720-05) / 3 mL in 1 CARTRIDGE (52817-720-01)Marketed from Feb 24, 2022 |
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)
- apomorphine hydrocloride
- Generic name (nonproprietary)
- apomorphine hydrochloride
- Active ingredients
- Apomorphine hydrochloride — 30 mg/3mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- TruPharma, LLCNDC labeler code 52817
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212025
- Marketing start
- Listing expires
- Other FDA classes
- Dopamine Agonists (Mechanism)
- Identifiers
- Product ID 52817-720_2fbd7414-f94f-4e18-8d0e-3ae69a5449f7SPL ID 2fbd7414-f94f-4e18-8d0e-3ae69a5449f7SPL set ID aedf70e4-1949-44bc-bf1b-0f282c4f0705RxCUI 855856UNII F39049Y068
- Pharmacologic class
- Dopaminergic 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
N452817072005followed by a unit qualifier and the quantityPackage 52817-0720-05. 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)
Apomorphine hydrochloride injection is indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) in patients with advanced Parkinson's disease. Apomorphine hydrocloride inejction has been studied as an adjunct to other medications [see Clinical Studies (14) ] . Apomorphine hydrocloride injection is a non-ergoline dopamine agonist indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) associated with advanced Parkinson's disease ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 52817-720
- What is NDC 52817-720?
- 52817-720 is the product NDC for apomorphine hydrocloride (apomorphine hydrochloride), Apomorphine hydrochloride 30 mg/3mL injection, listed with the FDA by TruPharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- apomorphine hydrocloride (Apomorphine hydrochloride).
- What is the active ingredient?
- Apomorphine hydrochloride.
- Who is the labeler?
- TruPharma, LLC, NDC labeler code 52817. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for apomorphine hydrocloride?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.