cromolyn sodium

Generic: cromolyn sodium

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name cromolyn sodium
Generic Name cromolyn sodium
Labeler mylan pharmaceuticals inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cromolyn sodium 100 mg/5mL

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 51525-0470
Product ID 51525-0470_b70d4285-ddb4-4e80-baf1-340f9572d903
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020479
Marketing Start 2015-10-21
Marketing End 2026-06-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 515250470
Hyphenated Format 51525-0470

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 NDA020479 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 12 POUCH in 1 CARTON (51525-0470-9) / 8 AMPULE in 1 POUCH (51525-0470-8) / 5 mL in 1 AMPULE
source: ndc

Packages (1)

51525-0470-9 12 POUCH in 1 CARTON (51525-0470-9) / 8 AMPULE in 1 POUCH (51525-0470-8) / 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": "b70d4285-ddb4-4e80-baf1-340f9572d903", "openfda": {"unii": ["Q2WXR1I0PK"], "rxcui": ["831261"], "spl_set_id": ["fbefd5bd-668a-4d10-b93e-a2e3fc5dddbd"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 POUCH in 1 CARTON (51525-0470-9)  / 8 AMPULE in 1 POUCH (51525-0470-8)  / 5 mL in 1 AMPULE", "package_ndc": "51525-0470-9", "marketing_end_date": "20260630", "marketing_start_date": "20151021"}], "brand_name": "cromolyn sodium", "product_id": "51525-0470_b70d4285-ddb4-4e80-baf1-340f9572d903", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Histamine Release [PE]", "Mast Cell Stabilizer [EPC]"], "product_ndc": "51525-0470", "generic_name": "cromolyn sodium", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "cromolyn sodium", "active_ingredients": [{"name": "CROMOLYN SODIUM", "strength": "100 mg/5mL"}], "application_number": "NDA020479", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20260630", "marketing_start_date": "20151021"}