Prescription drug · ANDA

Phenylephrine Hydrochloride NDC 65145-116

Phenylephrine hydrochloride 50 mg/5mL · Injection · Intravenous · Caplin Steriles Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)65145-116Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65145-0116Add 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
65145-116-0165145011601651450116011 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (65145-116-01) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGEMarketed from Apr 28, 2026
65145-116-10651450116106514501161010 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (65145-116-10) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGEMarketed from Apr 28, 2026

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 — 50 mg/5mL
Dosage form
Injection
Route
Intravenous
Labeler
Caplin Steriles LimitedNDC labeler code 65145
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213318
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha1-Agonists (Mechanism)
Identifiers
Product ID 65145-116_93087431-1c8f-4b1d-9ce3-0b42aa219a3fSPL ID 93087431-1c8f-4b1d-9ce3-0b42aa219a3fSPL set ID 1b9f1d54-ea46-49c8-a33e-c94a61bc0460RxCUI 1232651, 1666372UNII 04JA59TNSJUPC 0365145117014, 0365145116109, 0365145115010, 0365145115256, 0365145116017
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N465145011601 followed by a unit qualifier and the quantity

Package 65145-0116-01. 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)

Phenylephrine hydrochloride Injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Phenylephrine hydrochloride Injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65145-116

What is NDC 65145-116?
65145-116 is the product NDC for Phenylephrine Hydrochloride, Phenylephrine hydrochloride 50 mg/5mL injection, listed with the FDA by Caplin Steriles Limited. It has 2 package NDCs, 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Phenylephrine HydrochloridePhenylephrine hydrochloride 25 mg/mLSolution/ dropsOphthalmicFirst Nation Group, LLC81469-16881469-0168-0281469-0168-15
Phenylephrine HydrochloridePhenylephrine hydrochloride 100 mg/mLSolution/ dropsOphthalmicFirst Nation Group, LLC81469-16981469-0169-05
Phenylephrine HydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousFresenius Kabi USA, LLC65219-38865219-0388-01
Phenylephrine HydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousCaplin Steriles Limited65145-11565145-0115-25
Phenylephrine HydrochloridePhenylephrine hydrochloride 100 mg/10mLInjectionIntravenousCaplin Steriles Limited65145-11765145-0117-01
phenylephrine hydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousBaxter Healthcare Corporation36000-35836000-0358-25
phenylephrine hydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousBaxter Healthcare Corporation36000-36036000-0360-10
phenylephrine hydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousBaxter Healthcare Corporation36000-36236000-0362-05
Phenylephrine HydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousMethod Pharmaceuticals, LLC58657-85158657-0851-26
Phenylephrine HydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousMethod Pharmaceuticals, LLC58657-85258657-0852-11

All 108 Phenylephrine Hydrochloride NDCs

Other NDCs under ANDA 213318

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

FDA NDC Directory listings under ANDA 213318
ProductStrengthForm · routeLabelerProduct NDC
Phenylephrine HydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousCaplin Steriles Limited65145-115
Phenylephrine HydrochloridePhenylephrine hydrochloride 100 mg/10mLInjectionIntravenousCaplin Steriles Limited65145-117
Phenylephrine HydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousSomerset Therapeutics, LLC70069-801
Phenylephrine HydrochloridePhenylephrine hydrochloride 50 mg/5mLInjectionIntravenousSomerset Therapeutics, LLC70069-802
Phenylephrine HydrochloridePhenylephrine hydrochloride 100 mg/10mLInjectionIntravenousSomerset Therapeutics, LLC70069-803
Phenylephrine HydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousSomerset Therapeutics, LLC70069-811
Phenylephrine HydrochloridePhenylephrine hydrochloride 50 mg/5mLInjectionIntravenousSomerset Therapeutics, LLC70069-812
Phenylephrine HydrochloridePhenylephrine hydrochloride 100 mg/10mLInjectionIntravenousSomerset Therapeutics, LLC70069-813
Phenylephrine HydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousXellia Pharmaceuticals USA LLC70594-063
Phenylephrine HydrochloridePhenylephrine hydrochloride 50 mg/5mLInjectionIntravenousXellia Pharmaceuticals USA LLC70594-064
Phenylephrine HydrochloridePhenylephrine hydrochloride 100 mg/10mLInjectionIntravenousXellia Pharmaceuticals USA LLC70594-065
Phenylephrine HydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousMedical Purchasing Solutions, LLC71872-7273
Phenylephrine HydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousMedical Purchasing Solutions, LLC.71872-7348
Phenylephrine HydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousArmas Pharmaceuticals Inc.72485-504
Phenylephrine HydrochloridePhenylephrine hydrochloride 50 mg/5mLInjectionIntravenousArmas Pharmaceuticals Inc.72485-505
Phenylephrine HydrochloridePhenylephrine hydrochloride 100 mg/10mLInjectionIntravenousArmas Pharmaceuticals Inc.72485-506

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