Home NDC 24201-201 Sodium Tetradecyl Sulfate
Product NDC 24201-201
11-digit product format 242010201
Labeler code 24201
Product ID 24201-201_5c279d1b-193e-46d3-a28c-43a0d3f14f96
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Tetradecyl Sulfate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA209937
Marketing category ANDA
Marketing start 2019-12-09
Substance SODIUM TETRADECYL SULFATE
Active strength 30 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 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 A209937-001 SODIUM TETRADECYL SULFATE SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209937-001 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 2026-08-18 06:07:40 2026-07 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209937-001 SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) INJECTABLE / INJECTION AP 2019-12-09 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Sodium Tetradecyl Sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM TETRADECYL SULFATE 30 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q1SUG5KBD6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 204491 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 24201-201-01 Sodium Tetradecyl Sulfate 2 mL in 1 VIAL, GLASS INJECTION, SOLUTION 2 5 24201-201-05 Sodium Tetradecyl Sulfate 5 in 1 CARTON INJECTION, SOLUTION 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24201-201 SODIUM TETRADECYL SULFATE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240628_997394e1-ec1f-4093-e053-2a95a90a0ea0.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 24201-201-01 24201020101 2 mL in 1 VIAL, GLASS 2 ml Historical 24201-201-05 24201020105 5 VIAL, GLASS in 1 CARTON (24201-201-05) / 2 mL in 1 VIAL, GLASS (24201-201-01) 2019-12-09 0000-00-00 No No Current