gastrocrom

Generic: cromolyn sodium

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gastrocrom
Generic Name cromolyn sodium
Labeler viatris specialty llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

cromolyn sodium 20 mg/mL

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 0037-0678
Product ID 0037-0678_15aec235-80e7-4d95-b48c-bbca69b4b04d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020479
Listing Expiration 2026-12-31
Marketing Start 2015-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00370678
Hyphenated Format 0037-0678

Supplemental Identifiers

RxCUI
831261 831269
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 gastrocrom (source: ndc)
Generic Name cromolyn sodium (source: ndc)
Application Number NDA020479 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 12 POUCH in 1 CARTON (0037-0678-96) / 8 AMPULE in 1 POUCH (0037-0678-08) / 5 mL in 1 AMPULE
source: ndc

Packages (1)

0037-0678-96 12 POUCH in 1 CARTON (0037-0678-96) / 8 AMPULE in 1 POUCH (0037-0678-08) / 5 mL in 1 AMPULE

Ingredients (1)

cromolyn sodium (20 mg/mL)

Linked Drug Pages (1)

Gastrocrom ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "15aec235-80e7-4d95-b48c-bbca69b4b04d", "openfda": {"unii": ["Q2WXR1I0PK"], "rxcui": ["831261", "831269"], "spl_set_id": ["00623958-a8fe-47d1-a0d2-0aa4e2f7966e"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 POUCH in 1 CARTON (0037-0678-96)  / 8 AMPULE in 1 POUCH (0037-0678-08)  / 5 mL in 1 AMPULE", "package_ndc": "0037-0678-96", "marketing_start_date": "20150501"}], "brand_name": "Gastrocrom", "product_id": "0037-0678_15aec235-80e7-4d95-b48c-bbca69b4b04d", "dosage_form": "LIQUID", "pharm_class": ["Decreased Histamine Release [PE]", "Mast Cell Stabilizer [EPC]"], "product_ndc": "0037-0678", "generic_name": "cromolyn sodium", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gastrocrom", "active_ingredients": [{"name": "CROMOLYN SODIUM", "strength": "20 mg/mL"}], "application_number": "NDA020479", "marketing_category": "NDA", "marketing_start_date": "20150501", "listing_expiration_date": "20261231"}