NDC codes

FDA NDC Directory
Product NDC (as listed)50090-0516Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-0516Add 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
50090-0516-0500900516001 POUCH in 1 CARTON (50090-0516-0) / 25 mL in 1 POUCHMarketed from Jun 29, 2016
50090-0516-1500900516015 POUCH in 1 CARTON (50090-0516-1) / 25 mL in 1 POUCHMarketed from Jun 29, 2016

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Albuterol Sulfate
Generic name (nonproprietary)
albuterol sulfate
Active ingredients
Albuterol sulfate — 2.5 mg/3mL
Dosage form
Solution
Route
Respiratory (Inhalation)
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077839
Marketing start
Listing expires
Other FDA classes
Adrenergic beta2-Agonists (Mechanism)
Identifiers
Product ID 50090-0516_6ece0588-777b-4260-acea-6f1f4d0fbdbbSPL ID 6ece0588-777b-4260-acea-6f1f4d0fbdbbSPL set ID 19867b61-77a2-46f1-97c7-7fadfec5882bRxCUI 630208UNII 021SEF3731
Pharmacologic class
beta2-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.

NDC on a medical claim

N450090051600 followed by a unit qualifier and the quantity

Package 50090-0516-00. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 077839

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

FDA NDC Directory listings under ANDA 077839
ProductStrengthForm · routeLabelerProduct NDC
Albuterol SulfateAlbuterol sulfate 2.5 mg/3mLSolutionRespiratory (Inhalation)Ritedose Pharmaceuticals, LLC76204-200
Albuterol SulfateAlbuterol sulfate 2.5 mg/3mLSolutionRespiratory (Inhalation)Medical Purchasing Solutions, LLC71872-7054
Albuterol SulfateAlbuterol sulfate 2.5 mg/3mLSolutionRespiratory (Inhalation)Mylan Pharmaceuticals Inc.0378-8270
Albuterol SulfateAlbuterol sulfate 2.5 mg/3mLSolutionRespiratory (Inhalation)Cardinal Health 107, LLC55154-4410
Albuterol SulfateAlbuterol sulfate 2.5 mg/3mLSolutionRespiratory (Inhalation)Cardinal Health 107, LLC55154-2132
Albuterol SulfateAlbuterol sulfate 2.5 mg/3mLSolutionRespiratory (Inhalation)American Health Packaging60687-395
Albuterol SulfateAlbuterol sulfate 2.5 mg/3mLSolutionRespiratory (Inhalation)NuCare Pharmaceuticals, Inc.68071-3780
Albuterol SulfateAlbuterol sulfate 2.5 mg/3mLSolutionRespiratory (Inhalation)Preferred Pharmaceuticals Inc.68788-8399

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