Prescription drug · ANDA
Pilocarpine Hydrochloride NDC 69315-316
Pilocarpine hydrochloride 40 mg/mL · Solution/ drops · Ophthalmic · Leading Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69315-316-15 | 6931503161569315031615 | 15 mL in 1 BOTTLE, PLASTIC (69315-316-15)Marketed from Oct 20, 2026 |
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)
- Pilocarpine Hydrochloride
- Generic name (nonproprietary)
- pilocarpine hydrochloride
- Active ingredients
- Pilocarpine hydrochloride — 40 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Leading Pharma, LLCNDC labeler code 69315
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217052
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Agonists (Mechanism)Cholinergic Muscarinic Agonists (Mechanism)
- Identifiers
- Product ID 69315-316_13a208d9-c611-443a-bb0c-f52651994f36SPL ID 13a208d9-c611-443a-bb0c-f52651994f36SPL set ID 189762b1-608a-4240-b1b5-0db3278224bbRxCUI 1000647, 1000862, 1000897UNII 0WW6D218XJUPC 0369315316153, 0369315315156, 0369315314159
- 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
N469315031615followed by a unit qualifier and the quantityPackage 69315-0316-15. 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: Pilocarpine hydrochloride ophthalmic solution is a muscarinic cholinergic agonist indicated for: The reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. (1.1) The management of acute angle-closure glaucoma. (1.2) The prevention of postoperative elevated IOP associated with laser surgery. (1.3) The induction of miosis. (1.4) 1.1 Reduction of Elevated Intraocular Pressure (IOP) in Patients with Open-Angle Glaucoma or Ocular Hypertension. 1.2 Management of Acute Angle-Closure Glaucoma 1.3 Prevention of Postoperative Elevated IOP Associated with Laser Surgery 1.4 Inductio…
Excerpt only. Read the full label for complete information.
About NDC 69315-316
- What is NDC 69315-316?
- 69315-316 is the product NDC for Pilocarpine Hydrochloride, Pilocarpine hydrochloride 40 mg/mL solution/ drops, listed with the FDA by Leading Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pilocarpine Hydrochloride.
- What is the active ingredient?
- Pilocarpine hydrochloride.
- Who is the labeler?
- Leading Pharma, LLC, NDC labeler code 69315. 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?
- 21 other product NDCs are listed under this name. See all Pilocarpine Hydrochloride 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 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 | Pilocarpine hydrochloride 5 mg/1 | Tablet, Film coatedOral | AMICI PHARMACEUTICALS LLC | 69292-265 | 69292-0265-01 |
| Pilocarpine Hydrochloride | Pilocarpine hydrochloride 5 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-652 | 50268-0652-12 |
| Pilocarpine Hydrochloride | Pilocarpine hydrochloride 10 mg/mL | Solution/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 69238-1745 | 69238-1745-08 |
| Pilocarpine Hydrochloride | Pilocarpine hydrochloride 20 mg/mL | Solution/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 69238-1746 | 69238-1746-08 |
| Pilocarpine Hydrochloride | Pilocarpine hydrochloride 40 mg/mL | Solution/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 69238-1747 | 69238-1747-08 |
| Pilocarpine Hydrochloridepilocarpine hydrochloride ophthalmic solution | Pilocarpine hydrochloride 10 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-181 | 70069-0181-01 |
| Pilocarpine Hydrochloridepilocarpine hydrochloride ophthalmic solution | Pilocarpine hydrochloride 20 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-191 | 70069-0191-01 |
| Pilocarpine Hydrochloridepilocarpine hydrochloride ophthalmic solution | Pilocarpine hydrochloride 40 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-201 | 70069-0201-01 |
| Pilocarpine Hydrochloride | Pilocarpine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-224 | 59651-0224-01 |
| Pilocarpine Hydrochloride | Pilocarpine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-225 | 59651-0225-01 |
Other NDCs under ANDA 217052
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 | Pilocarpine hydrochloride 10 mg/mL | Solution/ dropsOphthalmic | Leading Pharma, LLC | 69315-314 |
| Pilocarpine Hydrochloride | Pilocarpine hydrochloride 20 mg/mL | Solution/ dropsOphthalmic | Leading Pharma, LLC | 69315-315 |