NDC codes

FDA NDC Directory
Product NDC (as listed)72162-2563Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72162-2563Add 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
72162-2563-172162256301100 CAPSULE in 1 BOTTLE (72162-2563-1)Marketed from Nov 4, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Cevimeline Hydrochloride
Generic name (nonproprietary)
cevimeline hydrochloride
Active ingredients
Cevimeline hydrochloride — 30 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 72162
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215056
Marketing start
Listing expires
Other FDA classes
Cholinergic Muscarinic Agonists (Mechanism)
Identifiers
Product ID 72162-2563_fb360aef-a237-424f-95a0-f39d33113bd7SPL ID fb360aef-a237-424f-95a0-f39d33113bd7SPL set ID 71ada1b0-3344-4202-9277-57f1a37402c1RxCUI 309140UNII P81Q6V85NP
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

N472162256301 followed by a unit qualifier and the quantity

Package 72162-2563-01. 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)

INDICATIONS AND USAGE Cevimeline hydrochloride capsules are indicated for the treatment of symptoms of dry mouth in patients with Sjögren’s Syndrome.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72162-2563

What is NDC 72162-2563?
72162-2563 is the product NDC for Cevimeline Hydrochloride, Cevimeline hydrochloride 30 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cevimeline Hydrochloride.
What is the active ingredient?
Cevimeline hydrochloride.
Who is the labeler?
Bryant Ranch Prepack, NDC labeler code 72162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cevimeline Hydrochloride?
16 other product NDCs are listed under this name. See all Cevimeline 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 Cevimeline Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Cevimeline HydrochlorideCevimeline hydrochloride 30 mg/1CapsuleOralZydus Lifesciences Limited70771-198270771-1982-01
Cevimeline HydrochlorideCevimeline hydrochloride 30 mg/1CapsuleOralViona Pharmaceuticals Inc72578-20872578-0208-01
Cevimeline HydrochlorideCevimeline hydrochloride 30 mg/1CapsuleOralMacleods Pharmaceuticals Limited33342-21633342-0216-11
Cevimeline HydrochlorideCevimeline hydrochloride 30 mg/1CapsuleOralAurobindo Pharma Limited59651-42259651-0422-0159651-0422-05
Cevimeline HydrochlorideCevimeline hydrochloride 30 mg/1CapsuleOralBryant Ranch Prepack71335-232671335-2326-0171335-2326-0271335-2326-03
Cevimeline HydrochlorideCevimeline hydrochloride 30 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-45772789-0457-0172789-0457-30
Cevimeline HydrochlorideCevimeline hydrochloride 30 mg/1CapsuleOralAdvagen Pharma Ltd72888-11872888-0118-0072888-0118-0172888-0118-05+1 more
cevimeline hydrochlorideCevimeline hydrochloride 30 mg/1CapsuleOralCosette Pharmaceuticals, Inc.0713-093700713-0937-01
cevimeline hydrochlorideCevimeline hydrochloride 30 mg/1CapsuleOralBryant Ranch Prepack71335-316871335-3168-0171335-3168-0271335-3168-03
cevimeline hydrochlorideCevimeline hydrochloride 30 mg/1CapsuleOralNovel Laboratories, Inc.40032-99940032-0999-0140032-0999-0340032-0999-05

All 17 Cevimeline Hydrochloride NDCs

Other NDCs under ANDA 215056

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

FDA NDC Directory listings under ANDA 215056
ProductStrengthForm · routeLabelerProduct NDC
Cevimeline HydrochlorideCevimeline hydrochloride 30 mg/1CapsuleOralAurobindo Pharma Limited59651-422

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