Cromolyn Sodium Inhalation Solution, USP

Cromolyn Sodium Inhalation Solution by

Drug Labeling and Warnings

Cromolyn Sodium Inhalation Solution by is a Prescription medication manufactured, distributed, or labeled by Holopack Verpackungstechnik GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CROMOLYN SODIUM INHALATION SOLUTION- cromolyn sodium solution 
Holopack Verpackungstechnik GmbH

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Cromolyn Sodium Inhalation Solution, USP

Cromolyn Sodium Inhalation Solution, USP

Cromolyn Sodium Inhalation Solution, USP

999

20 mg/2 mL Rx only

NDC Code Fera: 48102-033-60

NDC Code Holopack: 60940-032-01

Store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature.

Distrubuted by:

Fera Pharmaceuticals, LLC

Locust Valley, NY 11560

Mfd. By:

Holopack Verpackungstechnik GmbH

Bahnhofstr., 74429 Sulzbach-Laufen

Germany

Holopack Material No.: 011-01512

EXP 08/2023 LOT TEST03 QTY20

(17)230830(10)TEST03(30)20

(01)10348102033609(21)12345678901234

Label

CROMOLYN SODIUM INHALATION SOLUTION 
cromolyn sodium solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60940-032
Route of AdministrationINTRABRONCHIAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CROMOLYN SODIUM (UNII: Q2WXR1I0PK) (CROMOLYN - UNII:Y0TK0FS77W) CROMOLYN SODIUM20 mg  in 2 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 60940-032-015 in 1 CARTON11/30/2021
16 in 1 POUCH
12 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07543711/30/2021
Labeler - Holopack Verpackungstechnik GmbH (313222457)
Establishment
NameAddressID/FEIBusiness Operations
Holopack Verpackungstechnik GmbH343390324manufacture(60940-032)

Revised: 11/2021
Document Id: d0d730f8-3407-9f18-e053-2995a90a34c7
Set id: d0d730f8-3406-9f18-e053-2995a90a34c7
Version: 1
Effective Time: 20211115