What is NDC 0378-7057?

0378-7057 is the product NDC for Albuterol, Albuterol sulfate .63 mg/3mL solution, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, 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?

15 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Albuterol NDC 0378-7057 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-7057Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-7057Add 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	Copy
0378-7057-52	0037870575200378705752	5 POUCH in 1 CARTON (0378-7057-52) / 5 VIAL in 1 POUCH (0378-7057-98) / 3 mL in 1 VIALMarketed from Oct 7, 2022

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
Generic name (nonproprietary): albuterol
Active ingredients: Albuterol sulfate — .63 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 214531
Marketing start: Oct 7, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)
Identifiers: Product ID 0378-7057_6e4e9eff-5117-47b1-a43f-58a45cd90457SPL ID 6e4e9eff-5117-47b1-a43f-58a45cd90457SPL set ID 9e6e982b-7dfe-45b8-aa76-754e8d2a8ef6RxCUI 351136, 351137UNII 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

N400378705752 followed by a unit qualifier and the quantity

Package 00378-7057-52. 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 Mar 15, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Albuterol Inhalation Solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-7057

What is NDC 0378-7057?: 0378-7057 is the product NDC for Albuterol, Albuterol sulfate .63 mg/3mL solution, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Albuterol.
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?: 15 other product NDCs are listed under this name. See all Albuterol 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Albuterolalbuterol sulfate	Albuterol sulfate 90 ug/1	Aerosol, MeteredRespiratory (Inhalation)	Cipla USA Inc.	69097-021	69097-0021-60
Albuterol	Albuterol sulfate 1.25 mg/3mL	SolutionRespiratory (Inhalation)	Mylan Pharmaceuticals Inc.	0378-7058	00378-7058-52
Albuterol	Albuterol sulfate 2 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	70710-1061	70710-1061-01
Albuterol	Albuterol sulfate 4 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	70710-1062	70710-1062-0170710-1062-05
Albuterol	Albuterol sulfate 2 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1511	70771-1511-01
Albuterol	Albuterol sulfate 4 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1512	70771-1512-0170771-1512-05
Albuterol	Albuterol sulfate 2 mg/1	TabletOral	Aurobindo Pharma Limited	59651-333	59651-0333-0159651-0333-05
Albuterol	Albuterol sulfate 4 mg/1	TabletOral	Aurobindo Pharma Limited	59651-334	59651-0334-0159651-0334-05
Albuterol	Albuterol sulfate 4 mg/1	TabletOral	Bryant Ranch Prepack	63629-2611	63629-2611-0163629-2611-0263629-2611-03
Albuterol	Albuterol sulfate 2 mg/1	TabletOral	Rising Pharma Holdings, Inc.	64980-442	64980-0442-0164980-0442-50

All 16 Albuterol NDCs

Other NDCs under ANDA 214531

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

FDA NDC Directory listings under ANDA 214531
Product	Strength	Form · route	Labeler	Product NDC
Albuterol	Albuterol sulfate 1.25 mg/3mL	SolutionRespiratory (Inhalation)	Mylan Pharmaceuticals Inc.	0378-7058
Albuterol Sulfate Inhalation Solutionalbuterol sulfate	Albuterol sulfate .63 mg/3mL	SolutionRespiratory (Inhalation)	Ritedose Pharmaceuticals, LLC	76204-010
Albuterol Sulfate Inhalation Solutionalbuterol sulfate	Albuterol sulfate 1.25 mg/3mL	SolutionRespiratory (Inhalation)	Ritedose Pharmaceuticals, LLC	76204-011