What is NDC 65862-858?

65862-858 is the product NDC for Albuterol Sulfate, Albuterol sulfate .83 mg/mL solution, listed with the FDA by Aurobindo Pharma Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Albuterol Sulfate?

90 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Albuterol Sulfate NDC 65862-858 | National Drug Code

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 LimitedNDC labeler code 65862
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.

About NDC 65862-858

What is NDC 65862-858?: 65862-858 is the product NDC for Albuterol Sulfate, Albuterol sulfate .83 mg/mL solution, listed with the FDA by Aurobindo Pharma Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Albuterol Sulfate.
What is the active ingredient?: Albuterol sulfate.
Who is the labeler?: Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Albuterol Sulfate?: 90 other product NDCs are listed under this name. See all Albuterol Sulfate 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 Albuterol Sulfate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Albuterol Sulfate	Albuterol sulfate 108 ug/1	Aerosol, MeteredRespiratory (Inhalation)	REMEDYREPACK INC.	70518-4528	70518-4528-00
Albuterol Sulfate	Albuterol sulfate 90 ug/1	InhalantRespiratory (Inhalation)	Preferred Pharmaceuticals, Inc.	68788-4041	68788-4041-02
Albuterol Sulfate	Albuterol sulfate 90 ug/1	InhalantRespiratory (Inhalation)	REMEDYREPACK INC.	70518-4496	70518-4496-00
Albuterol Sulfate	Albuterol sulfate .83 mg/mL	SolutionRespiratory (Inhalation)	REMEDYREPACK INC.	70518-4490	70518-4490-00
Albuterol sulfate	Albuterol sulfate 90 ug/1	Aerosol, MeteredRespiratory (Inhalation)	Preferred Pharmaceuticals, Inc.	68788-8878	68788-8878-02
Albuterol Sulfate	Albuterol sulfate 90 ug/1	InhalantRespiratory (Inhalation)	Preferred Pharmaceuticals Inc.	68788-8874	68788-8874-02
Albuterol Sulfate	Albuterol sulfate 2.5 mg/.5mL	SolutionRespiratory (Inhalation)	Rising Pharma Holdings, Inc.	64980-642	64980-0642-03
Albuterol Sulfate	Albuterol sulfate .63 mg/3mL	SolutionRespiratory (Inhalation)	Rising Pharma Holdings, Inc	64980-643	64980-0643-03
Albuterol Sulfate	Albuterol sulfate 1.25 mg/3mL	SolutionRespiratory (Inhalation)	Rising Pharma Holdings, Inc	64980-644	64980-0644-02
Albuterol Sulfate	Albuterol sulfate 2.5 mg/3mL	SolutionRespiratory (Inhalation)	Rising Pharma Holdings, Inc.	64980-641	64980-0641-0264980-0641-0364980-0641-06

All 91 Albuterol Sulfate NDCs

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