Sotradecol

Product NDC: 67457-162
11-digit product format: 674570162
Labeler code: 67457
Product ID: 67457-162_ddecdc4b-0bd4-4b20-a0ac-3c0fa542c14f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tetradecyl hydrogen sulfate (ester)
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Mylan Institutional LLC
Application: ANDA040541
Marketing category: ANDA
Marketing start: 2013-04-29
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 42.

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.

Product history page 1 of 3 · 84 observed 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	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040541-001	SOTRADECOL	20MG/2ML (10MG/ML)	INJECTABLE / INJECTION		RS	2004-11-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040541-002	SOTRADECOL	60MG/2ML (30MG/ML)	INJECTABLE / INJECTION	AP	RS	2004-11-12	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040541-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040541-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040541-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040541-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040541-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040541-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040541-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040541-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040541-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040541-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040541-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040541-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040541-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040541-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040541-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040541-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040541-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040541-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A040541-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040541-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040541-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040541-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040541-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040541-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040541-002	AP	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040541-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040541-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040541-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040541-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040541-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040541-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040541-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040541-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040541-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040541-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040541-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040541-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040541-002	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040541-002	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sotradecol
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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
204490	Internal RxNorm lookup
204491	Internal RxNorm lookup
543732	Internal RxNorm lookup
543739	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f1756c28-dcd2-4b49-be62-07ca20682018	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
6ab7971f-36bb-4938-80a6-13935f0c3f67	Product name	1	20200526
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67457-162-00	Sotradecol	2 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	2		12
67457-162-02	Sotradecol	5 in 1 CARTON	INJECTION, SOLUTION	5		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67457-162-00	ML - Milliliter	67457-162	36031f5a-8eee-4f20-a527-7f4942e88ff1	1	2017-03-06
67457-162-02	ML - Milliliter	67457-162	a1c93556-2466-4fc9-92fe-15f4e074681c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TETRADECYL HYDROGEN SULFATE (ESTER)	ACTIVE INGREDIENT	6326W0DRHY	SOTRADECOL (TETRADECYL HYDROGEN SULFATE (ESTER)) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	6
TETRADECYL HYDROGEN SULFATE (ESTER)	ACTIVE MOIETY	6326W0DRHY	SOTRADECOL (TETRADECYL HYDROGEN SULFATE (ESTER)) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	6
Benzyl Alcohol	INACTIVE INGREDIENT	LKG8494WBH	SOTRADECOL (TETRADECYL HYDROGEN SULFATE (ESTER)) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	6
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	SOTRADECOL (TETRADECYL HYDROGEN SULFATE (ESTER)) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	6
Water	INACTIVE INGREDIENT	059QF0KO0R	SOTRADECOL (TETRADECYL HYDROGEN SULFATE (ESTER)) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67457-162	SOTRADECOL (TETRADECYL HYDROGEN SULFATE (ESTER)) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	12	Current NDC, Legacy NDC, 2 package rows	20211130_f1756c28-dcd2-4b49-be62-07ca20682018.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SODIUM TETRADECYL SULFATE	SODIUM TETRADECYL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	c76f4b3b-9f93-349f-e053-2995a90a2d57	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040541 application number: ANDA040541
Sotradecol	TETRADECYL HYDROGEN SULFATE (ESTER)	Mylan Institutional LLC	f1756c28-dcd2-4b49-be62-07ca20682018	2021-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040541 application number: ANDA040541 ndc (product): 67457-162
(SOTRADECOL) SODIUM TETRADECYL SULFATE	(SOTRADECOL) SODIUM TETRADECYL SULFATE	HF Acquisition Co LLC, DBA HealthFirst	c59db022-bda8-1732-e053-2a95a90a24f8	2021-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040541 application number: ANDA040541

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6326W0DRHY	TETRADECYL HYDROGEN SULFATE (ESTER)	300-52-7	TETRADECYL HYDROGEN SULFATE (ESTER)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
204490	sodium tetradecyl sulfate 1 % Injectable Solution	PSN	f1756c28-dcd2-4b49-be62-07ca20682018	12
204491	sodium tetradecyl sulfate 3 % Injectable Solution	PSN	f1756c28-dcd2-4b49-be62-07ca20682018	12
543732	Sotradecol 1 % Injectable Solution	PSN	f1756c28-dcd2-4b49-be62-07ca20682018	12
543739	Sotradecol 3 % Injectable Solution	PSN	f1756c28-dcd2-4b49-be62-07ca20682018	12
543732	sodium tetradecyl sulfate 10 MG/ML Injectable Solution [Sotradecol]	SBD	f1756c28-dcd2-4b49-be62-07ca20682018	12
543739	sodium tetradecyl sulfate 30 MG/ML Injectable Solution [Sotradecol]	SBD	f1756c28-dcd2-4b49-be62-07ca20682018	12
204490	sodium tetradecyl sulfate 10 MG/ML Injectable Solution	SCD	f1756c28-dcd2-4b49-be62-07ca20682018	12
204491	sodium tetradecyl sulfate 30 MG/ML Injectable Solution	SCD	f1756c28-dcd2-4b49-be62-07ca20682018	12
204490	sodium tetradecyl sulfate 1 % Injectable Solution	SY	f1756c28-dcd2-4b49-be62-07ca20682018	12
204491	sodium tetradecyl sulfate 3 % Injectable Solution	SY	f1756c28-dcd2-4b49-be62-07ca20682018	12
543732	Sotradecol 1 % Injectable Solution	SY	f1756c28-dcd2-4b49-be62-07ca20682018	12
543732	Sotradecol 10 MG/ML Injectable Solution	SY	f1756c28-dcd2-4b49-be62-07ca20682018	12
543739	Sotradecol 3 % Injectable Solution	SY	f1756c28-dcd2-4b49-be62-07ca20682018	12
543739	Sotradecol 30 MG/ML Injectable Solution	SY	f1756c28-dcd2-4b49-be62-07ca20682018	12
204490	sodium tetradecyl sulfate 1 % Injectable Solution	PSN	c76f4b3b-9f93-349f-e053-2995a90a2d57	2
204490	sodium tetradecyl sulfate 10 MG/ML Injectable Solution	SCD	c76f4b3b-9f93-349f-e053-2995a90a2d57	2
204490	sodium tetradecyl sulfate 1 % Injectable Solution	SY	c76f4b3b-9f93-349f-e053-2995a90a2d57	2
204490	sodium tetradecyl sulfate 1 % Injectable Solution	PSN	23b7b990-2ecc-4b3a-8233-03c3b2584800	1
543732	Sotradecol 1 % Injectable Solution	PSN	23b7b990-2ecc-4b3a-8233-03c3b2584800	1
543732	sodium tetradecyl sulfate 10 MG/ML Injectable Solution [Sotradecol]	SBD	23b7b990-2ecc-4b3a-8233-03c3b2584800	1
204490	sodium tetradecyl sulfate 10 MG/ML Injectable Solution	SCD	23b7b990-2ecc-4b3a-8233-03c3b2584800	1
204490	sodium tetradecyl sulfate 1 % Injectable Solution	SY	23b7b990-2ecc-4b3a-8233-03c3b2584800	1
543732	Sotradecol 1 % Injectable Solution	SY	23b7b990-2ecc-4b3a-8233-03c3b2584800	1
543732	Sotradecol 10 MG/ML Injectable Solution	SY	23b7b990-2ecc-4b3a-8233-03c3b2584800	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67457-162-00	67457016200	2 mL in 1 VIAL, MULTI-DOSE	2 ml					Historical
67457-162-02	67457016202	5 VIAL, MULTI-DOSE in 1 CARTON (67457-162-02) / 2 mL in 1 VIAL, MULTI-DOSE (67457-162-00)		2013-04-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SOTRADECOL® 1% (SODIUM TETRADECYL SULFATE INJECTION) 20mg/2mL (10mg/mL)	HF Acquisition Co LLC, DBA HealthFirst	2024-02-22	HUMAN PRESCRIPTION DRUG LABEL	2
SOTRADECOL ® (Sodium Tetradecyl Sulfate Injection)	Mylan Institutional LLC	2021-08-17	HUMAN PRESCRIPTION DRUG LABEL	12
SOTRADECOL ® (Sodium Tetradecyl Sulfate Injection)	A-S Medication Solutions	2019-09-17	HUMAN PRESCRIPTION DRUG LABEL	1