Pilocarpine Hydrochloride NDC 61314-203

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-203Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0203Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
61314-203-15	61314020315	1 BOTTLE in 1 CARTON (61314-203-15) / 15 mL in 1 BOTTLEMarketed from Sep 30, 2011

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 — 10 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Sandoz Inc
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 200890
Marketing start: Sep 30, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Agonists (Mechanism)Cholinergic Muscarinic Agonists (Mechanism)
Identifiers: Product ID 61314-203_305559df-eb9c-4584-b5c5-0a83505b4bb0SPL ID 305559df-eb9c-4584-b5c5-0a83505b4bb0SPL set ID 53fa0b7a-f982-48a7-92c4-6f098683c1edRxCUI 1000647, 1000862, 1000897UNII 0WW6D218XJ
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

N461314020315 followed by a unit qualifier and the quantity

Package 61314-0203-15. 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 May 19, 2020.

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 S…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 200890

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 200890
Product	Strength	Form · route	Labeler	Product NDC
Pilocarpine Hydrochloride	Pilocarpine hydrochloride 20 mg/mL	Solution/ dropsOphthalmic	Sandoz Inc	61314-204
Pilocarpine Hydrochloride	Pilocarpine hydrochloride 40 mg/mL	Solution/ dropsOphthalmic	Sandoz Inc	61314-206