Home NDC 0487-5901 S2
Product NDC 0487-5901
11-digit product format 004875901
Labeler code 0487
Product ID 0487-5901_495453e6-2060-edaa-e063-6394a90a8a5d
Type HUMAN OTC DRUG
Nonproprietary name racepinephrine hydrochloride
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Nephron Pharmaceuticals Corporation
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2000-01-01
Substance RACEPINEPHRINE HYDROCHLORIDE
Active strength 11.25 mg/.5mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 S2
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RACEPINEPHRINE HYDROCHLORIDE 11.25 mg/.5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 336096P2WE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310133 Internal RxNorm lookup 863968 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0487-5901-99 S2 30 in 1 CARTON SOLUTION 30 12 0487-5901-99 S2 1 in 1 POUCH SOLUTION 1 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0487-5901 S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON SC, INC.] 11 Current NDC, Legacy NDC, 2 package rows 20241222_dd1b35c7-b23b-4b95-8162-df3d263fe32e.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 98 of 180 · 3,583 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 0487-5901-99 00487590199 30 POUCH in 1 CARTON (0487-5901-99) / 1 VIAL, SINGLE-USE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-USE 30 pouch 2000-01-01 0000-00-00 No No Current