NDC codes

FDA NDC Directory
Product NDC (as listed)0781-7296Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-7296Add 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
0781-7296-85007817296851 CANISTER in 1 CARTON (0781-7296-85) / 200 AEROSOL, METERED in 1 CANISTERMarketed from Mar 15, 2021

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Albuterol Sulfate
Generic name (nonproprietary)
albuterol sulfate
Active ingredients
Albuterol sulfate — 108 ug/1
Dosage form
Aerosol, Metered
Route
Respiratory (Inhalation)
Labeler
Sandoz Inc
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 020503
Marketing start
Listing expires
Other FDA classes
Adrenergic beta2-Agonists (Mechanism)
Identifiers
Product ID 0781-7296_44ec30c6-e178-d2ed-e063-6394a90a25a5SPL ID 44ec30c6-e178-d2ed-e063-6394a90a25a5SPL set ID f8a2c4b7-a162-48ab-90b0-350e4da25c66RxCUI 2123111UNII 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

N400781729685 followed by a unit qualifier and the quantity

Package 00781-7296-85. 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)

INDICATIONS AND USAGE Albuterol Sulfate Inhalation Aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020503

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

FDA NDC Directory listings under NDA 020503
ProductStrengthForm · routeLabelerProduct NDC
Albuterol SulfateAlbuterol sulfate 108 ug/1Aerosol, MeteredRespiratory (Inhalation)Preferred Pharmaceuticals Inc.68788-7996
Albuterol SulfateAlbuterol sulfate 108 ug/1Aerosol, MeteredRespiratory (Inhalation)REMEDYREPACK INC.70518-4528
Albuterol SulfateAlbuterol sulfate 108 ug/1Aerosol, MeteredRespiratory (Inhalation)Proficient Rx LP82804-036

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