Is Ailex Pharmaceuticals, LLC FDA approved?

Ailex Pharmaceuticals, LLC holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Ailex Pharmaceuticals, LLC make?

1 product is listed under Ailex Pharmaceuticals, LLC in the openFDA NDC Directory, most often as injection, solution, concentrate. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Are any Ailex Pharmaceuticals, LLC products in shortage?

3 presentations are currently listed in the FDA drug shortage database under Ailex Pharmaceuticals, LLC, covering Cromolyn Sodium Concentrate.

Ailex Pharmaceuticals, LLC

Data as of 30 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 1
Live patents: 0
Shortage listings: 3
Countries: 0

Alert

Drug shortage listings

Drug	Presentation	Status	Availability	Posted / updated
Cromolyn Sodium ConcentratePulmonary/Allergy	Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 76204-025-96)	Current	Limited Availability	3 Nov 202330 Sept 2026
Cromolyn Sodium ConcentratePulmonary/Allergy	Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 81665-104-96)	Current	Available	3 Nov 202330 Sept 2026
Cromolyn Sodium ConcentratePulmonary/Allergy	Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 69784-200-96)	Current	Limited Availability	3 Nov 202330 Sept 2026

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
SODIUM PHENYLACETATE and SODIUM BENZOATE	sodium phenylacetate and sodium benzoate	injection, solution, concentrate, intravenous	70556-100ANDA

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Enquiry

Common questions

Is Ailex Pharmaceuticals, LLC FDA approved?: Ailex Pharmaceuticals, LLC holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Ailex Pharmaceuticals, LLC make?: 1 product is listed under Ailex Pharmaceuticals, LLC in the openFDA NDC Directory, most often as injection, solution, concentrate. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Are any Ailex Pharmaceuticals, LLC products in shortage?: 3 presentations are currently listed in the FDA drug shortage database under Ailex Pharmaceuticals, LLC, covering Cromolyn Sodium Concentrate.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.