Albuterol Sulfate NDC 65862-858

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-858Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0858Add 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 NDC	11-digit (billing)	Package
65862-858-03	65862085803	30 POUCH in 1 CARTON (65862-858-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 17, 2017
65862-858-25	65862085825	5 POUCH in 1 CARTON (65862-858-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 17, 2017
65862-858-30	65862085830	6 POUCH in 1 CARTON (65862-858-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 17, 2017
65862-858-60	65862085860	12 POUCH in 1 CARTON (65862-858-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 17, 2017

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): Albuterol Sulfate
Generic name (nonproprietary): albuterol sulfate
Active ingredients: Albuterol sulfate — .83 mg/mL
Dosage form: Solution
Route: Respiratory (Inhalation)
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206224
Marketing start: Oct 17, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)
Identifiers: Product ID 65862-858_5b820396-5863-567e-e063-6394a90a7ee4SPL ID 5b820396-5863-567e-e063-6394a90a7ee4
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

N465862085803 followed by a unit qualifier and the quantity

Package 65862-0858-03. 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.

Other NDCs under ANDA 206224

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

FDA NDC Directory listings under ANDA 206224
Product	Strength	Form · route	Labeler	Product NDC
Albuterol Sulfate	Albuterol sulfate .83 mg/mL	SolutionRespiratory (Inhalation)	REMEDYREPACK INC.	70518-4490
Albuterol Sulfate	Albuterol sulfate .83 mg/mL	SolutionRespiratory (Inhalation)	Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.	81894-104