Home NDC 51662-1562 SODIUM TETRADECYL SULFATE
Product NDC 51662-1562
11-digit product format 516621562
Labeler code 51662
Product ID 51662-1562_1203bbfe-c55f-1bcb-e063-6394a90a6577
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM TETRADECYL SULFATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA040541
Marketing category ANDA
Marketing start 2021-07-18
Substance TETRADECYL HYDROGEN SULFATE (ESTER)
Active strength 10 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040541-001 SOTRADECOL SODIUM TETRADECYL SULFATE 20MG/2ML (10MG/ML) INJECTABLE / INJECTION RS 2004-11-12 A040541-002 SOTRADECOL SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP RS 2004-11-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040541-002 AP
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 2026-08-01 22:54:32 2026-06 A040541-001 SOTRADECOL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION RS 2004-11-12 a50c72e98297…2026-08-01 22:54:32 2026-06 A040541-002 SOTRADECOL 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP RS 2004-11-12 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A040541-002 AP 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base SODIUM TETRADECYL SULFATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TETRADECYL HYDROGEN SULFATE (ESTER) 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6326W0DRHY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 204490 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 51662-1562-1 SODIUM TETRADECYL SULFATE 2 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 2 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1562 SODIUM TETRADECYL SULFATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 2 Current NDC, Legacy NDC, 1 package rows 20240224_c76f4b3b-9f93-349f-e053-2995a90a2d57.zip
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 51662-1562-1 51662156201 2 mL in 1 VIAL, MULTI-DOSE (51662-1562-1) 2 ml 2021-07-18 0000-00-00 No No Current