What is NDC 61314-016?

61314-016 is the product NDC for Proparacaine Hydrochloride, Proparacaine hydrochloride 5 mg/mL solution/ drops, listed with the FDA by Sandoz Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Sandoz Inc., NDC labeler code 61314. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Proparacaine Hydrochloride?

11 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Proparacaine Hydrochloride NDC 61314-016

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-016Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0016Add 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
61314-016-01	61314001601	1 BOTTLE in 1 CARTON (61314-016-01) / 15 mL in 1 BOTTLEMarketed from Jun 5, 2000

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): Proparacaine Hydrochloride
Generic name (nonproprietary): proparacaine hydrochloride
Active ingredients: Proparacaine hydrochloride — 5 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Sandoz Inc.NDC labeler code 61314
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 080027
Marketing start: Jun 5, 2000
Listing expires: Dec 31, 2026
Other FDA classes: Local Anesthesia (Physiologic effect)
Identifiers: Product ID 61314-016_ca203740-1e54-4289-9a1f-f2086fec4f46SPL ID ca203740-1e54-4289-9a1f-f2086fec4f46SPL set ID 447a2a64-0507-4fe8-bb44-cc36c3916151RxCUI 1191013UNII U96OL57GOYUPC 0361314016010
Pharmacologic class: Local Anesthetic

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

N461314001601 followed by a unit qualifier and the quantity

Package 61314-0016-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

About NDC 61314-016

What is NDC 61314-016?: 61314-016 is the product NDC for Proparacaine Hydrochloride, Proparacaine hydrochloride 5 mg/mL solution/ drops, listed with the FDA by Sandoz Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Proparacaine Hydrochloride.
What is the active ingredient?: Proparacaine hydrochloride.
Who is the labeler?: Sandoz Inc., NDC labeler code 61314. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Proparacaine Hydrochloride?: 11 other product NDCs are listed under this name. See all Proparacaine 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 Proparacaine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Proparacaine hydrochloride	Proparacaine hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	Micro Labs Limited	42571-497	42571-0497-57
Proparacaine hydrochloride	Proparacaine hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	Lifestar Pharma LLC	70756-193	70756-0193-35
Proparacaine Hydrochloride	Proparacaine hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	Somerset Therapeutics, LLC	70069-601	70069-0601-01
Proparacaine Hydrochloride	Proparacaine hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	Sportpharm LLC	85766-039	85766-0039-15
Proparacaine Hydrochloride	Proparacaine hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	REMEDYREPACK INC.	70518-3408	70518-3408-00
Proparacaine Hydrochloride	Proparacaine hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	Sportpharm LLC	85766-056	85766-0056-15
Proparacaine Hydrochloride	Proparacaine hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	Bausch & Lomb Incorporated	24208-730	24208-0730-06
Proparacaine Hydrochloride	Proparacaine hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	A-S Medication Solutions	50090-1923	50090-1923-00
Proparacaine Hydrochloride	Proparacaine hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	NuCare Pharmaceuticals,Inc.	68071-4368	68071-4368-05
Proparacaine Hydrochloride	Proparacaine hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	Sportpharm LLC	85766-057	85766-0057-15

All 12 Proparacaine Hydrochloride NDCs

Other NDCs under ANDA 080027

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

FDA NDC Directory listings under ANDA 080027
Product	Strength	Form · route	Labeler	Product NDC
Alcaineproparacaine hydrochloride	Proparacaine hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	Alcon Laboratories, Inc.	0998-0016
proparacaine hydrochloride	Proparacaine hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	NuCare Pharmaceuticals,Inc.	68071-5139
Proparacaine Hydrochloride	Proparacaine hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	REMEDYREPACK INC.	70518-3408
Proparacaine Hydrochloride	Proparacaine hydrochloride 5 mg/mL	Solution/ dropsOphthalmic	Sportpharm LLC	85766-056