Home NDC 77338-305 astonea
Product NDC 77338-305
11-digit product format 773380305
Labeler code 77338
Product ID 77338-305_1bbae087-0d0a-67d2-e063-6294a90a8320
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler ASTONEA LABS PRIVATE LIMITED
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-05-02
Substance HYDROCORTISONE ACETATE
Active strength 10 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base astonea
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE ACETATE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3X7931PO74 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1043690 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 77338-305-02 astonea 0.9 g in 1 PACKET CREAM 0.9 4 77338-305-03 astonea 28.3 g in 1 TUBE CREAM 28.3 4 77338-305-06 astonea 454 g in 1 JAR CREAM 454 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 77338-305 ASTONEA (HYDROCORTISONE) CREAM [ASTONEA LABS PRIVATE LIMITED] 4 Current NDC, Legacy NDC, 3 package rows 20240627_de09e859-c5fd-0cc5-e053-2a95a90a147e.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 18 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 77338-305-02 77338030502 .9 g in 1 PACKET (77338-305-02) 2022-05-02 0000-00-00 No No Current 77338-305-03 77338030503 28.3 g in 1 TUBE (77338-305-03) 28.3 g 2022-05-02 0000-00-00 No No Current 77338-305-06 77338030506 454 g in 1 JAR (77338-305-06) 454 g 2022-05-02 0000-00-00 No No Current