Cromolyn Sodium

Product NDC
69784-205
11-digit product format
697840205
Labeler code
69784
Product ID
69784-205_fd9a8121-c6e6-47d6-b324-283786f6e7ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cromolyn Sodium
Dosage form
SOLUTION
Route
INTRABRONCHIAL
Labeler
Woodward Pharma Services LLC
Application
ANDA209453
Marketing category
ANDA
Marketing start
2017-10-16
Marketing end
0000-00-00
Substance
CROMOLYN SODIUM
Active strength
20 mg/2mL
Pharmacologic classes
Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69784-205-30ML - Milliliter69784-2050b285c9c-7614-4399-8fb8-f65390e5c22a12017-11-06
69784-205-60ML - Milliliter69784-205b00efcab-a5f6-4b1e-a240-83863b795a2d12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69784-205CROMOLYN SODIUM SOLUTION [WOODWARD PHARMA SERVICES LLC]5Legacy NDC20220731_9038746e-20fc-4c64-b3ab-f96dfad5b9db.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69784-205-60697840205602 POUCH in 1 CARTON (69784-205-60) > 30 VIAL, SINGLE-DOSE in 1 POUCH (69784-205-30) > 2 mL in 1 VIAL, SINGLE-DOSE2 pouch2017-10-160000-00-00NoNoCurrent