What is NDC 61314-396?

61314-396 is the product NDC for Cyclopentolate Hydrochloride, Cyclopentolate hydrochloride 10 mg/mL solution, listed with the FDA by Sandoz Inc.. It has 3 package NDCs, 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 Cyclopentolate Hydrochloride?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cyclopentolate Hydrochloride NDC 61314-396

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-396Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0396Add 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
61314-396-01	6131403960161314039601	2 mL in 1 BOTTLE (61314-396-01)Marketed from Aug 22, 2002
61314-396-02	6131403960261314039602	5 mL in 1 BOTTLE (61314-396-02)Marketed from Aug 22, 2002
61314-396-03	6131403960361314039603	15 mL in 1 BOTTLE (61314-396-03)Marketed from Aug 22, 2002

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): Cyclopentolate Hydrochloride
Generic name (nonproprietary): cyclopentolate hydrochloride
Active ingredients: Cyclopentolate hydrochloride — 10 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Sandoz Inc.NDC labeler code 61314
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 084110
Marketing start: Aug 22, 2002
Listing expires: Dec 31, 2026
Identifiers: Product ID 61314-396_6b554ca9-699a-4d71-8e46-0130c675ca3cSPL ID 6b554ca9-699a-4d71-8e46-0130c675ca3cSPL set ID c1b44f91-356d-4804-9509-3b457f4809e5RxCUI 1298066UNII 736I6971TEUPC 0361314396037

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

N461314039601 followed by a unit qualifier and the quantity

Package 61314-0396-01. 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 21, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61314-396

What is NDC 61314-396?: 61314-396 is the product NDC for Cyclopentolate Hydrochloride, Cyclopentolate hydrochloride 10 mg/mL solution, listed with the FDA by Sandoz Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cyclopentolate Hydrochloride.
What is the active ingredient?: Cyclopentolate 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 Cyclopentolate Hydrochloride?: 1 other product NDC are listed under this name. See all Cyclopentolate 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 Cyclopentolate Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cyclopentolate Hydrochloride	Cyclopentolate hydrochloride 10 mg/mL	Solution/ dropsOphthalmic	Bausch & Lomb Incorporated	24208-735	24208-0735-0124208-0735-06

Other NDCs under ANDA 084110

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

FDA NDC Directory listings under ANDA 084110
Product	Strength	Form · route	Labeler	Product NDC
Cyclogylcyclopentolate hydrochloride	Cyclopentolate hydrochloride 10 mg/mL	Solution/ dropsOphthalmic	Alcon Laboratories, Inc.	0065-0396