NDC codes

FDA NDC Directory
Product NDC (as listed)70069-191Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70069-0191Add 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 NDC11-digit (billing)PackageCopy
70069-191-0170069019101700690191011 BOTTLE in 1 CARTON (70069-191-01) / 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 — 20 mg/mL
Dosage form
Solution/ drops
Route
Ophthalmic
Labeler
Somerset Therapeutics, LLCNDC labeler code 70069
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210384
Marketing start
Listing expires
Other FDA classes
Cholinergic Agonists (Mechanism)Cholinergic Muscarinic Agonists (Mechanism)
Identifiers
Product ID 70069-191_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

N470069019101 followed by a unit qualifier and the quantity

Package 70069-0191-01. 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 .

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)

About NDC 70069-191

What is NDC 70069-191?
70069-191 is the product NDC for Pilocarpine Hydrochloride, Pilocarpine hydrochloride 20 mg/mL solution/ drops, listed with the FDA by Somerset Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pilocarpine Hydrochloride (Pilocarpine Hydrochloride Ophthalmic Solution).
What is the active ingredient?
Pilocarpine hydrochloride.
Who is the labeler?
Somerset Therapeutics, LLC, NDC labeler code 70069. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Pilocarpine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pilocarpine HydrochloridePilocarpine hydrochloride 5 mg/1Tablet, Film coatedOralAMICI PHARMACEUTICALS LLC69292-26569292-0265-01
Pilocarpine HydrochloridePilocarpine hydrochloride 5 mg/1Tablet, Film coatedOralAvPAK50268-65250268-0652-12
Pilocarpine HydrochloridePilocarpine hydrochloride 10 mg/mLSolution/ dropsOphthalmicAmneal Pharmaceuticals NY LLC69238-174569238-1745-08
Pilocarpine HydrochloridePilocarpine hydrochloride 20 mg/mLSolution/ dropsOphthalmicAmneal Pharmaceuticals NY LLC69238-174669238-1746-08
Pilocarpine HydrochloridePilocarpine hydrochloride 40 mg/mLSolution/ dropsOphthalmicAmneal Pharmaceuticals NY LLC69238-174769238-1747-08
Pilocarpine Hydrochloridepilocarpine hydrochloride ophthalmic solutionPilocarpine hydrochloride 10 mg/mLSolution/ dropsOphthalmicSomerset Therapeutics, LLC70069-18170069-0181-01
Pilocarpine Hydrochloridepilocarpine hydrochloride ophthalmic solutionPilocarpine hydrochloride 40 mg/mLSolution/ dropsOphthalmicSomerset Therapeutics, LLC70069-20170069-0201-01
Pilocarpine HydrochloridePilocarpine hydrochloride 5 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-22459651-0224-01
Pilocarpine HydrochloridePilocarpine hydrochloride 7.5 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-22559651-0225-01
Pilocarpine hydrochloridePilocarpine hydrochloride 5 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-92868084-0928-25

All 22 Pilocarpine Hydrochloride NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
Pilocarpine Hydrochloridepilocarpine hydrochloride ophthalmic solutionPilocarpine hydrochloride 10 mg/mLSolution/ dropsOphthalmicSomerset Therapeutics, LLC70069-181
Pilocarpine Hydrochloridepilocarpine hydrochloride ophthalmic solutionPilocarpine hydrochloride 40 mg/mLSolution/ dropsOphthalmicSomerset Therapeutics, LLC70069-201

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