Prescription drug · ANDA

Phenylephrine Hydrochloride NDC 70069-812

Phenylephrine hydrochloride 50 mg/5mL · Injection · Intravenous · Somerset Therapeutics, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)70069-812Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70069-0812Add 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
70069-812-107006908121010 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70069-812-10) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (70069-812-01)Marketed from Jul 17, 2023

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
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 70069-812_18b65b44-fdd1-4385-b6f8-cf3cbdc8d0e6SPL ID 18b65b44-fdd1-4385-b6f8-cf3cbdc8d0e6SPL set ID 18b65b44-fdd1-4385-b6f8-cf3cbdc8d0e6RxCUI 1232651, 1666372UNII 04JA59TNSJUPC 0370069813010
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

N470069081210 followed by a unit qualifier and the quantity

Package 70069-0812-10. 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)

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 50 mg/5mLInjectionIntravenousCaplin Steriles Limited65145-116
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 100 mg/10mLInjectionIntravenousSomerset Therapeutics, LLC70069-813
Phenylephrine HydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousMedical Purchasing Solutions, LLC71872-7273
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, LLC.71872-7348
Phenylephrine HydrochloridePhenylephrine hydrochloride 100 mg/10mLInjectionIntravenousArmas Pharmaceuticals Inc.72485-506
Phenylephrine HydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousArmas Pharmaceuticals Inc.72485-504
Phenylephrine HydrochloridePhenylephrine hydrochloride 50 mg/5mLInjectionIntravenousArmas Pharmaceuticals Inc.72485-505

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