Home NDC 68071-2357-2 Phenazopyridine Hydrochloride
Product NDC 68071-2357
Requested package NDC 68071-2357-2
11-digit product format 680712357
Labeler code 68071
Product ID 68071-2357_4b34f7e8-fb23-1311-e063-6294a90a3a1c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenazopyridine
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2011-02-01
Substance PHENAZOPYRIDINE HYDROCHLORIDE
Active strength 100 mg/1
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 · 7 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Additional Listing Data#
Finished product Yes
Brand name base Phenazopyridine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENAZOPYRIDINE HYDROCHLORIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0EWG668W17 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1094107 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-2357-2 Phenazopyridine Hydrochloride 12 in 1 BOTTLE TABLET 12 3 68071-2357-4 Phenazopyridine Hydrochloride 4 in 1 BOTTLE TABLET 4 3 68071-2357-8 Phenazopyridine Hydrochloride 8 in 1 BOTTLE TABLET 8 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-2357 PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [NUCARE PHARMACEUTICALS,INC.] 2 Current NDC, Legacy NDC, 3 package rows 20250112_bd0ae1dc-f170-eda6-e053-2995a90a6c9b.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 1 of 1 · 1 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 68071-2357-2 68071235702 12 TABLET in 1 BOTTLE (68071-2357-2) 12 tablet 2021-03-08 0000-00-00 No No Current