What is NDC 65145-149?

65145-149 is the product NDC for Phenylephrine Hydrochloride, Phenylephrine hydrochloride 25 mg/mL solution/ drops, listed with the FDA by Caplin Steriles Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Caplin Steriles Limited, NDC labeler code 65145. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Phenylephrine Hydrochloride?

107 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Phenylephrine Hydrochloride NDC 65145-149

NDC codes

FDA NDC Directory

Product NDC (as listed)65145-149Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65145-0149Add 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
65145-149-01	6514501490165145014901	1 BOTTLE, DROPPER in 1 CARTON (65145-149-01) / 15 mL in 1 BOTTLE, DROPPERMarketed from Jan 23, 2025

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): Phenylephrine Hydrochloride
Generic name (nonproprietary): phenylephrine hydrochloride
Active ingredients: Phenylephrine hydrochloride — 25 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Caplin Steriles LimitedNDC labeler code 65145
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215183
Marketing start: Jan 23, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)
Identifiers: Product ID 65145-149_606202d3-4976-427a-8ced-f8ae0c2a9a4cSPL ID 606202d3-4976-427a-8ced-f8ae0c2a9a4cSPL set ID 1b3eec91-5be5-4010-bf92-4c3e72b39b2aRxCUI 1234571, 1234579UNII 04JA59TNSJUPC 0365145148018, 0365145150011, 0365145149015
Pharmacologic class: alpha-1 Adrenergic 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

N465145014901 followed by a unit qualifier and the quantity

Package 65145-0149-01. 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 Jan 23, 2025.

Indications (excerpt from the label)

Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil Phenylephrine Hydrochloride Ophthalmic Solution is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65145-149

What is NDC 65145-149?: 65145-149 is the product NDC for Phenylephrine Hydrochloride, Phenylephrine hydrochloride 25 mg/mL solution/ drops, listed with the FDA by Caplin Steriles Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Phenylephrine Hydrochloride.
What is the active ingredient?: Phenylephrine hydrochloride.
Who is the labeler?: Caplin Steriles Limited, NDC labeler code 65145. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Phenylephrine Hydrochloride?: 107 other product NDCs are listed under this name. See all Phenylephrine 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 Phenylephrine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 25 mg/mL	Solution/ dropsOphthalmic	First Nation Group, LLC	81469-168	81469-0168-0281469-0168-15
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 100 mg/mL	Solution/ dropsOphthalmic	First Nation Group, LLC	81469-169	81469-0169-05
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 10 mg/mL	InjectionIntravenous	Fresenius Kabi USA, LLC	65219-388	65219-0388-01
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 10 mg/mL	InjectionIntravenous	Caplin Steriles Limited	65145-115	65145-0115-25
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 50 mg/5mL	InjectionIntravenous	Caplin Steriles Limited	65145-116	65145-0116-0165145-0116-10
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 100 mg/10mL	InjectionIntravenous	Caplin Steriles Limited	65145-117	65145-0117-01
phenylephrine hydrochloride	Phenylephrine hydrochloride 10 mg/mL	InjectionIntravenous	Baxter Healthcare Corporation	36000-358	36000-0358-25
phenylephrine hydrochloride	Phenylephrine hydrochloride 10 mg/mL	InjectionIntravenous	Baxter Healthcare Corporation	36000-360	36000-0360-10
phenylephrine hydrochloride	Phenylephrine hydrochloride 10 mg/mL	InjectionIntravenous	Baxter Healthcare Corporation	36000-362	36000-0362-05
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 10 mg/mL	InjectionIntravenous	Method Pharmaceuticals, LLC	58657-851	58657-0851-26

All 108 Phenylephrine Hydrochloride NDCs

Other NDCs under ANDA 215183

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

FDA NDC Directory listings under ANDA 215183
Product	Strength	Form · route	Labeler	Product NDC
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 25 mg/mL	Solution/ dropsOphthalmic	Caplin Steriles Limited	65145-148
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 100 mg/mL	Solution/ dropsOphthalmic	Caplin Steriles Limited	65145-150
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 25 mg/mL	SolutionOphthalmic	Leading Pharma, LLC	69315-323
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 100 mg/mL	SolutionOphthalmic	Leading Pharma, LLC	69315-324
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 25 mg/mL	Solution/ dropsOphthalmic	SOLA Pharmaceuticals, LLC	70512-865
Phenylephrine Hydrochloride	Phenylephrine hydrochloride 100 mg/mL	Solution/ dropsOphthalmic	SOLA Pharmaceuticals, LLC	70512-866