Premasol - sulfite-free (Amino Acid)

Product NDC: 0338-1131
11-digit product format: 003381131
Labeler code: 0338
Product ID: 0338-1131_49eb2f11-79ad-47ec-8c8f-7ebbf0490285
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: ANDA075880
Marketing category: ANDA
Marketing start: 2003-06-19
Marketing end: 0000-00-00
Substance: LEUCINE; LYSINE ACETATE; ISOLEUCINE; VALINE; HISTIDINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; TYROSINE; ARGININE; PROLINE; ALANINE; GLUTAMIC ACID; SERINE; GLYCINE; ASPARTIC ACID; TAURINE; CYSTEINE HYDROCHLORIDE
Active strength: 1 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; g/100mL
Pharmacologic classes: Amino Acid [EPC],Amino Acids [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0338-1131		D	Discontinued by firm		2026-10-05
excluded package	package	0338-1131	0338-1131-03	D	Discontinued by firm		2026-10-05

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0338-1131-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0338-1131-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0338-1131-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0338-1131-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0338-1131-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0338-1131-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0338-1131-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0338-1131-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0338-1131-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0338-1131-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0338-1131-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0338-1131-03	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	AMINO ACIDS	6% (6GM/100ML)	INJECTABLE / INJECTION			2003-06-19
A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	AMINO ACIDS	10% (10GM/100ML)	INJECTABLE / INJECTION			2003-06-19

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075880-001	PREMASOL 6% IN PLASTIC CONTAINER	6% (6GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075880-002	PREMASOL 10% IN PLASTIC CONTAINER	10% (10GM/100ML)	INJECTABLE / INJECTION	2003-06-19	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2e254488-9fcb-41b3-a7c3-e2c9a3941b29	Product name	1	20200603
b4ff0805-126a-406d-9cae-fc34fd8e8889	Product name	1	20190711
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-1131-03	Premasol - sulfite-free (Amino Acid)	500 mL in 1 BAG	INJECTION, SOLUTION	500		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-1131-03	ML - Milliliter	0338-1131	d27739ee-97d6-4bab-9b90-6212fa07dd92	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALANINE	ACTIVE INGREDIENT	OF5P57N2ZX	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
ARGININE	ACTIVE INGREDIENT	94ZLA3W45F	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
ASPARTIC ACID	ACTIVE INGREDIENT	30KYC7MIAI	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
CYSTEINE HYDROCHLORIDE	ACTIVE INGREDIENT	ZT934N0X4W	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
GLUTAMIC ACID	ACTIVE INGREDIENT	3KX376GY7L	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
GLYCINE	ACTIVE INGREDIENT	TE7660XO1C	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
HISTIDINE	ACTIVE INGREDIENT	4QD397987E	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
ISOLEUCINE	ACTIVE INGREDIENT	04Y7590D77	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
LEUCINE	ACTIVE INGREDIENT	GMW67QNF9C	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
LYSINE ACETATE	ACTIVE INGREDIENT	TTL6G7LIWZ	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
METHIONINE	ACTIVE INGREDIENT	AE28F7PNPL	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
PHENYLALANINE	ACTIVE INGREDIENT	47E5O17Y3R	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
PROLINE	ACTIVE INGREDIENT	9DLQ4CIU6V	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
SERINE	ACTIVE INGREDIENT	452VLY9402	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
TAURINE	ACTIVE INGREDIENT	1EQV5MLY3D	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
THREONINE	ACTIVE INGREDIENT	2ZD004190S	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
TRYPTOPHAN	ACTIVE INGREDIENT	8DUH1N11BX	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
TYROSINE	ACTIVE INGREDIENT	42HK56048U	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
VALINE	ACTIVE INGREDIENT	HG18B9YRS7	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
ALANINE	ACTIVE MOIETY	OF5P57N2ZX	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
ARGININE	ACTIVE MOIETY	94ZLA3W45F	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
ASPARTIC ACID	ACTIVE MOIETY	30KYC7MIAI	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
CYSTEINE	ACTIVE MOIETY	K848JZ4886	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
GLUTAMIC ACID	ACTIVE MOIETY	3KX376GY7L	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
GLYCINE	ACTIVE MOIETY	TE7660XO1C	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
HISTIDINE	ACTIVE MOIETY	4QD397987E	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
ISOLEUCINE	ACTIVE MOIETY	04Y7590D77	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
LEUCINE	ACTIVE MOIETY	GMW67QNF9C	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
LYSINE	ACTIVE MOIETY	K3Z4F929H6	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
METHIONINE	ACTIVE MOIETY	AE28F7PNPL	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
PHENYLALANINE	ACTIVE MOIETY	47E5O17Y3R	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
PROLINE	ACTIVE MOIETY	9DLQ4CIU6V	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
SERINE	ACTIVE MOIETY	452VLY9402	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
TAURINE	ACTIVE MOIETY	1EQV5MLY3D	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
THREONINE	ACTIVE MOIETY	2ZD004190S	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
TRYPTOPHAN	ACTIVE MOIETY	8DUH1N11BX	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
TYROSINE	ACTIVE MOIETY	42HK56048U	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
VALINE	ACTIVE MOIETY	HG18B9YRS7	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
NITROGEN	INACTIVE INGREDIENT	N762921K75	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-1131	PREMASOL - SULFITE-FREE (AMINO ACID) (LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	10	Legacy NDC, 1 package rows	20240315_9afdcc3e-0d06-47f4-86ca-40da48b2b02b.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Premasol - sulfite-free (Amino Acid)	LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE	Baxter Healthcare Company	9afdcc3e-0d06-47f4-86ca-40da48b2b02b	2022-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075880 application number: ANDA075880 ndc (product): 0338-1131

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
GMW67QNF9C	LEUCINE	61-90-5	LEUCINE
TTL6G7LIWZ	LYSINE ACETATE	57282-49-2	LYSINE ACETATE
04Y7590D77	ISOLEUCINE	73-32-5	ISOLEUCINE
HG18B9YRS7	VALINE	72-18-4	VALINE
4QD397987E	HISTIDINE	71-00-1	HISTIDINE
47E5O17Y3R	PHENYLALANINE	63-91-2	PHENYLALANINE
2ZD004190S	THREONINE	72-19-5	THREONINE
AE28F7PNPL	METHIONINE	63-68-3	METHIONINE
8DUH1N11BX	TRYPTOPHAN	73-22-3	TRYPTOPHAN
42HK56048U	TYROSINE	60-18-4	TYROSINE
94ZLA3W45F	ARGININE	74-79-3	ARGININE
9DLQ4CIU6V	PROLINE	147-85-3	PROLINE
OF5P57N2ZX	ALANINE	56-41-7	ALANINE
3KX376GY7L	GLUTAMIC ACID	56-86-0	GLUTAMIC ACID
452VLY9402	SERINE	56-45-1	SERINE
TE7660XO1C	GLYCINE	56-40-6	GLYCINE
30KYC7MIAI	ASPARTIC ACID	56-84-8	ASPARTIC ACID
1EQV5MLY3D	TAURINE	107-35-7	TAURINE
ZT934N0X4W	CYSTEINE HYDROCHLORIDE	7048-04-6	CYSTEINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
801405	PremaSol 10 % Injectable Solution	PSN	9afdcc3e-0d06-47f4-86ca-40da48b2b02b	12
801398	PremaSol 6 % Injectable Solution	PSN	9afdcc3e-0d06-47f4-86ca-40da48b2b02b	12
801398	alanine 3.2 MG/ML / arginine 7.3 MG/ML / aspartate 1.9 MG/ML / cysteine 0.14 MG/ML / glutamate 3 MG/ML / glycine 2.2 MG/ML / histidine 2.9 MG/ML / isoleucine 4.9 MG/ML / leucine 8.4 MG/ML / lysine 4.9 MG/ML / methionine 2 MG/ML / phenylalanine 2.9 MG/ML / proline 4.1 MG/ML / serine 2.3 MG/ML / taurine 0.15 MG/ML / threonine 2.5 MG/ML / tryptophan 1.2 MG/ML / tyrosine 1.4 MG/ML / valine 4.7 MG/ML Injectable Solution [PremaSol]	SBD	9afdcc3e-0d06-47f4-86ca-40da48b2b02b	12
801405	alanine 5.4 MG/ML / arginine 12 MG/ML / aspartate 3.2 MG/ML / cysteine 0.16 MG/ML / glutamate 5 MG/ML / glycine 3.6 MG/ML / histidine 4.8 MG/ML / isoleucine 8.2 MG/ML / leucine 14 MG/ML / lysine 8.2 MG/ML / methionine 3.4 MG/ML / phenylalanine 4.8 MG/ML / proline 6.8 MG/ML / serine 3.8 MG/ML / taurine 0.25 MG/ML / threonine 4.2 MG/ML / tryptophan 2 MG/ML / tyrosine 2.4 MG/ML / valine 7.8 MG/ML Injectable Solution [PremaSol]	SBD	9afdcc3e-0d06-47f4-86ca-40da48b2b02b	12
801395	alanine 3.2 MG/ML / arginine 7.3 MG/ML / aspartate 1.9 MG/ML / cysteine 0.14 MG/ML / glutamate 3 MG/ML / glycine 2.2 MG/ML / histidine 2.9 MG/ML / isoleucine 4.9 MG/ML / leucine 8.4 MG/ML / lysine 4.9 MG/ML / methionine 2 MG/ML / phenylalanine 2.9 MG/ML / proline 4.1 MG/ML / serine 2.3 MG/ML / taurine 0.15 MG/ML / threonine 2.5 MG/ML / tryptophan 1.2 MG/ML / tyrosine 1.4 MG/ML / valine 4.7 MG/ML Injectable Solution	SCD	9afdcc3e-0d06-47f4-86ca-40da48b2b02b	12
801403	alanine 5.4 MG/ML / arginine 12 MG/ML / aspartate 3.2 MG/ML / cysteine 0.16 MG/ML / glutamate 5 MG/ML / glycine 3.6 MG/ML / histidine 4.8 MG/ML / isoleucine 8.2 MG/ML / leucine 14 MG/ML / lysine 8.2 MG/ML / methionine 3.4 MG/ML / phenylalanine 4.8 MG/ML / proline 6.8 MG/ML / serine 3.8 MG/ML / taurine 0.25 MG/ML / threonine 4.2 MG/ML / tryptophan 2 MG/ML / tyrosine 2.4 MG/ML / valine 7.8 MG/ML Injectable Solution	SCD	9afdcc3e-0d06-47f4-86ca-40da48b2b02b	12
801405	PremaSol 10 % Amino Acids Injectable Solution	SY	9afdcc3e-0d06-47f4-86ca-40da48b2b02b	12
801398	PremaSol 6 % Amino Acids Injectable Solution	SY	9afdcc3e-0d06-47f4-86ca-40da48b2b02b	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0338-1131-03	00338113103	500 mL in 1 BAG (0338-1131-03)	500 ml	2003-06-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PREMASOL 10% - sulfite-free (amino acids) injection in VIAFLEX Plastic Container	Baxter Healthcare Company \| Baxter Healthcare Corporation	2022-08-04	HUMAN PRESCRIPTION DRUG LABEL	12