cromolyn sodium

Generic: cromolyn sodium

Labeler: omnivium pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cromolyn sodium
Generic Name cromolyn sodium
Labeler omnivium pharmaceuticals llc
Dosage Form SOLUTION, CONCENTRATE
Routes
ORAL
Active Ingredients

cromolyn sodium 100 mg/5mL

Manufacturer
Omnivium Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 81665-104
Product ID 81665-104_fd09b0f1-907c-4d4d-a693-9756efd60f20
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209264
Listing Expiration 2027-12-31
Marketing Start 2024-08-31

Pharmacologic Class

Classes
decreased histamine release [pe] mast cell stabilizer [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81665104
Hyphenated Format 81665-104

Supplemental Identifiers

RxCUI
831261
UNII
Q2WXR1I0PK

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cromolyn sodium (source: ndc)
Generic Name cromolyn sodium (source: ndc)
Application Number ANDA209264 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 12 POUCH in 1 CARTON (81665-104-96) / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE
source: ndc

Packages (1)

81665-104-96 12 POUCH in 1 CARTON (81665-104-96) / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE

Ingredients (1)

cromolyn sodium (100 mg/5mL)

Linked Drug Pages (1)

CROMOLYN SODIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fd09b0f1-907c-4d4d-a693-9756efd60f20", "openfda": {"unii": ["Q2WXR1I0PK"], "rxcui": ["831261"], "spl_set_id": ["a742664b-265e-49f9-9744-d04e1fb620ae"], "manufacturer_name": ["Omnivium Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 POUCH in 1 CARTON (81665-104-96)  / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE", "package_ndc": "81665-104-96", "marketing_start_date": "20240831"}], "brand_name": "CROMOLYN SODIUM", "product_id": "81665-104_fd09b0f1-907c-4d4d-a693-9756efd60f20", "dosage_form": "SOLUTION, CONCENTRATE", "pharm_class": ["Decreased Histamine Release [PE]", "Mast Cell Stabilizer [EPC]"], "product_ndc": "81665-104", "generic_name": "CROMOLYN SODIUM", "labeler_name": "Omnivium Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CROMOLYN SODIUM", "active_ingredients": [{"name": "CROMOLYN SODIUM", "strength": "100 mg/5mL"}], "application_number": "ANDA209264", "marketing_category": "ANDA", "marketing_start_date": "20240831", "listing_expiration_date": "20271231"}