NDC codes

FDA NDC Directory
Product NDC (as listed)81469-169Labeler and product segments. Claims need a package NDC.
Product NDC at billing width81469-0169Add 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
81469-169-0581469016905814690169051 BOTTLE, DROPPER in 1 CARTON (81469-169-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Sep 1, 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 — 100 mg/mL
Dosage form
Solution/ drops
Route
Ophthalmic
Labeler
First Nation Group, LLCNDC labeler code 81469
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216496
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha1-Agonists (Mechanism)
Identifiers
Product ID 81469-169_1972fcbf-76e2-4860-9ffe-6a8ffe662ff9SPL ID 1972fcbf-76e2-4860-9ffe-6a8ffe662ff9
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

N481469016905 followed by a unit qualifier and the quantity

Package 81469-0169-05. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 81469-169

What is NDC 81469-169?
81469-169 is the product NDC for Phenylephrine Hydrochloride, Phenylephrine hydrochloride 100 mg/mL solution/ drops, listed with the FDA by First Nation Group, LLC. 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?
First Nation Group, LLC, NDC labeler code 81469. 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 10 mg/mLInjectionIntravenousFresenius Kabi USA, LLC65219-38865219-0388-01
Phenylephrine HydrochloridePhenylephrine hydrochloride 10 mg/mLInjectionIntravenousCaplin Steriles Limited65145-11565145-0115-25
Phenylephrine HydrochloridePhenylephrine hydrochloride 50 mg/5mLInjectionIntravenousCaplin Steriles Limited65145-11665145-0116-0165145-0116-10
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 216496

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

FDA NDC Directory listings under ANDA 216496
ProductStrengthForm · routeLabelerProduct NDC
Phenylephrine HydrochloridePhenylephrine hydrochloride 100 mg/mLSolution/ dropsOphthalmicLifestar Pharma LLC70756-614
Phenylephrine HydrochloridePhenylephrine hydrochloride 100 mg/mLSolution/ dropsOphthalmicNorthStar RxLLC72603-530

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