Pilocarpine Hydrochloride NDC 70069-201

NDC codes

FDA NDC Directory

Product NDC (as listed)70069-201Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70069-0201Add 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
70069-201-01	70069020101	1 BOTTLE in 1 CARTON (70069-201-01) / 15 mL in 1 BOTTLEMarketed from Nov 25, 2019

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 ophthalmic solution
Active ingredients: Pilocarpine hydrochloride — 40 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Somerset Therapeutics, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210384
Marketing start: Nov 25, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Cholinergic Agonists (Mechanism)Cholinergic Muscarinic Agonists (Mechanism)
Identifiers: Product ID 70069-201_82a2d0b0-5ac5-46a1-b945-1f5669cc75ecSPL ID 82a2d0b0-5ac5-46a1-b945-1f5669cc75ecSPL set ID 84428e9a-f486-44d9-ad93-4ea9069a6787RxCUI 1000647, 1000862, 1000897UNII 0WW6D218XJUPC 0370069191019, 0370069201015, 0370069181010
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

N470069020101 followed by a unit qualifier and the quantity

Package 70069-0201-01. 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 Dec 22, 2025.

Indications (excerpt from the label)

Pilocarpine hydrochloride ophthalmic solution, is indicated for the: Pilocarpine hydrochloride ophthalmic solution, USP 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210384

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

FDA NDC Directory listings under ANDA 210384
Product	Strength	Form · route	Labeler	Product NDC
Pilocarpine Hydrochloridepilocarpine hydrochloride ophthalmic solution	Pilocarpine hydrochloride 10 mg/mL	Solution/ dropsOphthalmic	Somerset Therapeutics, LLC	70069-181
Pilocarpine Hydrochloridepilocarpine hydrochloride ophthalmic solution	Pilocarpine hydrochloride 20 mg/mL	Solution/ dropsOphthalmic	Somerset Therapeutics, LLC	70069-191