What is NDC 69292-265?

69292-265 is the product NDC for Pilocarpine Hydrochloride, Pilocarpine hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by AMICI PHARMACEUTICALS LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

AMICI PHARMACEUTICALS LLC, NDC labeler code 69292. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pilocarpine Hydrochloride NDC 69292-265

NDC codes

FDA NDC Directory

Product NDC (as listed)69292-265Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69292-0265Add 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
69292-265-01	6929202650169292026501	100 TABLET, FILM COATED in 1 BOTTLE (69292-265-01)Marketed from Jul 26, 2022

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 — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: AMICI PHARMACEUTICALS LLCNDC labeler code 69292
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076963
Marketing start: Jul 26, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Cholinergic Agonists (Mechanism)Cholinergic Muscarinic Agonists (Mechanism)
Identifiers: Product ID 69292-265_e96671e2-f7a8-4d58-8b7f-35b9b7fab5a6SPL ID e96671e2-f7a8-4d58-8b7f-35b9b7fab5a6SPL set ID a86a7b63-5f6a-4c10-9270-24c7b7d50437RxCUI 1000913UNII 0WW6D218XJUPC 0369292265017
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N469292026501 followed by a unit qualifier and the quantity

Package 69292-0265-01. 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 Jun 12, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Pilocarpine hydrochloride tablets, USP are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren’s Syndrome.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69292-265

What is NDC 69292-265?: 69292-265 is the product NDC for Pilocarpine Hydrochloride, Pilocarpine hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by AMICI PHARMACEUTICALS 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?: AMICI PHARMACEUTICALS LLC, NDC labeler code 69292. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
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
Pilocarpine hydrochloride	Pilocarpine hydrochloride 5 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-928	68084-0928-25

All 22 Pilocarpine Hydrochloride NDCs