Prescription drug · ANDA
Pilocarpine Hydrochloride Ophthalmic (Pilocarpine hydrochloride) NDC 60219-2366
Pilocarpine hydrochloride 12.5 mg/mL · Solution/ drops · Ophthalmic · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60219-2366-2 | 6021923660260219236602 | 1 BOTTLE, DROPPER in 1 CARTON (60219-2366-2) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from May 1, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Pilocarpine Hydrochloride Ophthalmic
- Generic name (nonproprietary)
- pilocarpine hydrochloride
- Active ingredients
- Pilocarpine hydrochloride — 12.5 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Amneal Pharmaceuticals NY LLCNDC labeler code 60219
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217733
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Agonists (Mechanism)Cholinergic Muscarinic Agonists (Mechanism)
- Identifiers
- Product ID 60219-2366_a804f045-c81b-469d-848d-475bf8aac237SPL ID a804f045-c81b-469d-848d-475bf8aac237SPL set ID 93e37b61-7b90-4740-b0b4-17d39d3b03f6RxCUI 2584552UNII 0WW6D218XJUPC 0360219264915, 0360219236622
- Pharmacologic class
- Cholinergic Receptor 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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N460219236602followed by a unit qualifier and the quantityPackage 60219-2366-02. 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)
Pilocarpine hydrochloride ophthalmic solution is indicated for the treatment of presbyopia in adults. Pilocarpine hydrochloride is a cholinergic muscarinic receptor agonist indicated for the treatment of presbyopia in adults. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 60219-2366
- What is NDC 60219-2366?
- 60219-2366 is the product NDC for Pilocarpine Hydrochloride Ophthalmic, Pilocarpine hydrochloride 12.5 mg/mL solution/ drops, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pilocarpine Hydrochloride Ophthalmic (Pilocarpine Hydrochloride).
- What is the active ingredient?
- Pilocarpine hydrochloride.
- Who is the labeler?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 60219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pilocarpine Hydrochloride Ophthalmic?
- 1 other product NDC are listed under this name. See all Pilocarpine Hydrochloride Ophthalmic NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pilocarpine Hydrochloride Ophthalmic products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pilocarpine Hydrochloride Ophthalmicpilocarpine hydrochloride | Pilocarpine hydrochloride 12.5 mg/mL | Solution/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-2649 | 60219-2649-01 |
Other NDCs under ANDA 217733
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 |
|---|---|---|---|---|
| Pilocarpine Hydrochloride Ophthalmicpilocarpine hydrochloride | Pilocarpine hydrochloride 12.5 mg/mL | Solution/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 60219-2649 |