astonea

Generic: hydrocortisone

Labeler: astonea labs private limited
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name astonea
Generic Name hydrocortisone
Labeler astonea labs private limited
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone acetate 10 mg/g

Manufacturer
ASTONEA LABS PRIVATE LIMITED

Identifiers & Regulatory

Product NDC 77338-305
Product ID 77338-305_1bbae087-0d0a-67d2-e063-6294a90a8320
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2022-05-02

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 77338305
Hyphenated Format 77338-305

Supplemental Identifiers

RxCUI
1043690
UNII
3X7931PO74

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 astonea (source: ndc)
Generic Name hydrocortisone (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • .9 g in 1 PACKET (77338-305-02)
  • 28.3 g in 1 TUBE (77338-305-03)
  • 454 g in 1 JAR (77338-305-06)
source: ndc

Packages (3)

77338-305-02 .9 g in 1 PACKET (77338-305-02) 77338-305-03 28.3 g in 1 TUBE (77338-305-03) 77338-305-06 454 g in 1 JAR (77338-305-06)

Ingredients (1)

hydrocortisone acetate (10 mg/g)

Linked Drug Pages (1)

astonea ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1bbae087-0d0a-67d2-e063-6294a90a8320", "openfda": {"unii": ["3X7931PO74"], "rxcui": ["1043690"], "spl_set_id": ["de09e859-c5fd-0cc5-e053-2a95a90a147e"], "manufacturer_name": ["ASTONEA LABS PRIVATE LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": ".9 g in 1 PACKET (77338-305-02)", "package_ndc": "77338-305-02", "marketing_start_date": "20220502"}, {"sample": false, "description": "28.3 g in 1 TUBE (77338-305-03)", "package_ndc": "77338-305-03", "marketing_start_date": "20220502"}, {"sample": false, "description": "454 g in 1 JAR (77338-305-06)", "package_ndc": "77338-305-06", "marketing_start_date": "20220502"}], "brand_name": "astonea", "product_id": "77338-305_1bbae087-0d0a-67d2-e063-6294a90a8320", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "77338-305", "generic_name": "Hydrocortisone", "labeler_name": "ASTONEA LABS PRIVATE LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "astonea", "active_ingredients": [{"name": "HYDROCORTISONE ACETATE", "strength": "10 mg/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220502", "listing_expiration_date": "20261231"}