Home NDC 0363-6611 Pseudoephedrine Hydrochloride
Product NDC 0363-6611
11-digit product format 003636611
Labeler code 0363
Product ID 0363-6611_95e1422f-6442-48a0-a624-bf10ece0adec
Type HUMAN OTC DRUG
Nonproprietary name pseudoephedrine hydrochloride
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler WALGREEN CO.
Application ANDA218854
Marketing category ANDA
Marketing start 2026-01-30
Substance PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 240 mg/1
Pharmacologic classes Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218854-001 PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL RS 2025-12-29
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A218854-001 PSEUDOEPHEDRINE HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL RS 2025-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218854-001 PSEUDOEPHEDRINE HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL RS 2025-12-29 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218854-001 PSEUDOEPHEDRINE HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL RS 2025-12-29 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Pseudoephedrine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PSEUDOEPHEDRINE HYDROCHLORIDE 240 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6V9V2RYJ8N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049670 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0363-6611-10 Pseudoephedrine Hydrochloride 10 in 1 BLISTER PACK TABLET, EXTENDED RELEASE 10 2 0363-6611-10 Pseudoephedrine Hydrochloride 1 in 1 CARTON TABLET, EXTENDED RELEASE 1 2
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0363-6611-10 00363661110 1 BLISTER PACK in 1 CARTON (0363-6611-10) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 1 blister pack 2026-01-30 No No Current