What is NDC 0378-8270?

0378-8270 is the product NDC for Albuterol Sulfate, Albuterol sulfate 2.5 mg/3mL solution, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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?

91 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 0378-8270 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-8270Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-8270Add 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
0378-8270-52	0037882705200378827052	1 POUCH in 1 CARTON (0378-8270-52) / 25 AMPULE in 1 POUCH (0378-8270-62) / 3 mL in 1 AMPULEMarketed from Dec 18, 2012
0378-8270-55	0037882705500378827055	30 POUCH in 1 CARTON (0378-8270-55) / 1 AMPULE in 1 POUCH (0378-8270-31) / 3 mL in 1 AMPULEMarketed from Mar 6, 2014
0378-8270-91	0037882709100378827091	2 POUCH in 1 CARTON (0378-8270-91) / 30 AMPULE in 1 POUCH (0378-8270-64) / 3 mL in 1 AMPULEMarketed from Apr 11, 2013
0378-8270-93	0037882709300378827093	1 POUCH in 1 CARTON (0378-8270-93) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULEMarketed from Jan 22, 2013

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 — 2.5 mg/3mL
Dosage form: Solution
Route: Respiratory (Inhalation)
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077839
Marketing start: Oct 15, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)
Identifiers: Product ID 0378-8270_94ad4684-ceb9-4c5e-9635-a6edb5904cccSPL ID 94ad4684-ceb9-4c5e-9635-a6edb5904cccSPL set ID 5329614f-ae0b-4854-bb6f-ea0b7dae87c0RxCUI 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

N400378827052 followed by a unit qualifier and the quantity

Package 00378-8270-52. 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 Feb 10, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Albuterol inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-8270

What is NDC 0378-8270?: 0378-8270 is the product NDC for Albuterol Sulfate, Albuterol sulfate 2.5 mg/3mL solution, listed with the FDA by Mylan Pharmaceuticals Inc.. 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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?: 91 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 92 Albuterol Sulfate NDCs

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
Product	Strength	Form · route	Labeler	Product NDC
Albuterol Sulfate	Albuterol sulfate 2.5 mg/3mL	SolutionRespiratory (Inhalation)	A-S Medication Solutions	50090-0516
Albuterol Sulfate	Albuterol sulfate 2.5 mg/3mL	SolutionRespiratory (Inhalation)	Cardinal Health 107, LLC	55154-2132
Albuterol Sulfate	Albuterol sulfate 2.5 mg/3mL	SolutionRespiratory (Inhalation)	Cardinal Health 107, LLC	55154-4410
Albuterol Sulfate	Albuterol sulfate 2.5 mg/3mL	SolutionRespiratory (Inhalation)	American Health Packaging	60687-395
Albuterol Sulfate	Albuterol sulfate 2.5 mg/3mL	SolutionRespiratory (Inhalation)	NuCare Pharmaceuticals, Inc.	68071-3780
Albuterol Sulfate	Albuterol sulfate 2.5 mg/3mL	SolutionRespiratory (Inhalation)	Preferred Pharmaceuticals Inc.	68788-8399
Albuterol Sulfate	Albuterol sulfate 2.5 mg/3mL	SolutionRespiratory (Inhalation)	Medical Purchasing Solutions, LLC	71872-7054
Albuterol Sulfate	Albuterol sulfate 2.5 mg/3mL	SolutionRespiratory (Inhalation)	Ritedose Pharmaceuticals, LLC	76204-200