Albuterol Sulfate NDC 62135-189

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-189Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0189Add 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
62135-189-23	62135018923	2 TRAY in 1 BOX (62135-189-23) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (62135-189-20)Marketed from Mar 26, 2025
62135-189-24	62135018924	2 TRAY in 1 BOX (62135-189-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-189-05)Marketed from Mar 26, 2025
62135-189-41	62135018941	120 mL in 1 CONTAINER (62135-189-41)Marketed from Jun 8, 2022
62135-189-47	62135018947	473 mL in 1 CONTAINER (62135-189-47)Marketed from Jun 8, 2022

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 — 2 mg/5mL
Dosage form: Syrup
Route: Oral
Labeler: Chartwell RX, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077788
Marketing start: Jun 26, 2007
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta2-Agonists (Mechanism)
Identifiers: Product ID 62135-189_316befe4-1351-2acb-e063-6394a90a9a17SPL ID 316befe4-1351-2acb-e063-6394a90a9a17SPL set ID 560df50c-e2c4-459f-9d89-bf7e6588949eRxCUI 755497UNII 021SEF3731UPC 0362135189419, 0362135189471
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N462135018923 followed by a unit qualifier and the quantity

Package 62135-0189-23. 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 28, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Albuterol Sulfate Syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077788

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

FDA NDC Directory listings under ANDA 077788
Product	Strength	Form · route	Labeler	Product NDC
Albuterol Sulfate	Albuterol sulfate 2 mg/5mL	SyrupOral	Chartwell Governmental & Specialty RX, LLC.	68999-189