Cromolyn Sodium Inhalation

Product NDC
48102-033
11-digit product format
481020033
Labeler code
48102
Product ID
48102-033_d4183942-25bb-4995-b514-06e277ee5448
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cromolyn sodium
Dosage form
SOLUTION
Route
INTRABRONCHIAL
Labeler
Fera Pharmaceuticals, LLC
Application
ANDA075437
Marketing category
ANDA
Marketing start
2022-05-01
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48102-033-602022-05-20C16284748780-19855d018-d340-cd31-e053-dbdaa90ab51a739474c7-a3b0-4ba8-8f6b-f7988c742907
48102-033-602019-11-27C16284748780-19855d018-d340-cd31-e053-dbdaa90ab51a739474c7-a3b0-4ba8-8f6b-f7988c742907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48102-033-12ML - Milliliter48102-033f5f8d503-2452-4432-9643-e2d83e92ddb812022-06-06
48102-033-60ML - Milliliter48102-0335e907a02-74dd-4a5a-a73b-3515eea80c1a12022-06-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48102-033-60481020033605 POUCH in 1 CARTON (48102-033-60) > 12 VIAL, SINGLE-DOSE in 1 POUCH (48102-033-12) > 2 mL in 1 VIAL, SINGLE-DOSE5 pouch2022-05-010000-00-00NoNoCurrent