Premasol - sulfite-free (Amino Acid)

Product NDC: 0338-1130
11-digit product format: 003381130
Labeler code: 0338
Product ID: 0338-1130_c874a813-b145-4f7f-833e-97d6c4dd727c
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 Company
Application: ANDA075880
Marketing category: ANDA
Marketing start: 2003-06-19
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: 1.4; .82; .82; .78; .48; .48; .42; .34; .2; .24; 1.2; .68; .54; .5; .38; .36; .32; 25; .016 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: 2027-12-31
Current FDA listing: Yes

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.

Additional Listing Data#

Finished product: Yes
Brand name base: Premasol - sulfite-free (Amino Acid)
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEUCINE	1.4 g/100mL
LYSINE ACETATE	.82 g/100mL
ISOLEUCINE	.82 g/100mL
VALINE	.78 g/100mL
HISTIDINE	.48 g/100mL
PHENYLALANINE	.48 g/100mL
THREONINE	.42 g/100mL
METHIONINE	.34 g/100mL
TRYPTOPHAN	.2 g/100mL
TYROSINE	.24 g/100mL
ARGININE	1.2 g/100mL
PROLINE	.68 g/100mL
ALANINE	.54 g/100mL
GLUTAMIC ACID	.5 g/100mL
SERINE	.38 g/100mL
GLYCINE	.36 g/100mL
ASPARTIC ACID	.32 g/100mL
TAURINE	25 mg/100mL
CYSTEINE HYDROCHLORIDE	.016 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 19 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
GMW67QNF9C	Internal UNII lookup
TTL6G7LIWZ	Internal UNII lookup
04Y7590D77	Internal UNII lookup
HG18B9YRS7	Internal UNII lookup
4QD397987E	Internal UNII lookup
47E5O17Y3R	Internal UNII lookup
2ZD004190S	Internal UNII lookup
AE28F7PNPL	Internal UNII lookup
8DUH1N11BX	Internal UNII lookup
42HK56048U	Internal UNII lookup
94ZLA3W45F	Internal UNII lookup
9DLQ4CIU6V	Internal UNII lookup
OF5P57N2ZX	Internal UNII lookup
3KX376GY7L	Internal UNII lookup
452VLY9402	Internal UNII lookup
TE7660XO1C	Internal UNII lookup
30KYC7MIAI	Internal UNII lookup
1EQV5MLY3D	Internal UNII lookup
ZT934N0X4W	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
801395	Internal RxNorm lookup
801398	Internal RxNorm lookup
801403	Internal RxNorm lookup
801405	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
9afdcc3e-0d06-47f4-86ca-40da48b2b02b	Available on FDA.report

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	SPL version
0338-1130-03	Premasol - sulfite-free (Amino Acid)	500 mL in 1 BAG	INJECTION, SOLUTION	500	12
0338-1130-04	Premasol - sulfite-free (Amino Acid)	1000 mL in 1 BAG	INJECTION, SOLUTION	1000	12
0338-1130-06	Premasol - sulfite-free (Amino Acid)	2000 mL in 1 BAG	INJECTION, SOLUTION	2000	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-1130-03	ML - Milliliter	0338-1130	d19f9eba-b809-475b-92d8-dc351eb8d78f	1	2012-07-24
0338-1130-04	ML - Milliliter	0338-1130	9cba055e-6573-425b-aac6-6cd285e76078	1	2012-07-24
0338-1130-06	ML - Milliliter	0338-1130	9f8ad992-7fbc-44e8-a280-9063b6d52e49	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
0338-1130	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	Current NDC, Legacy NDC, 3 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): 0338-1130

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
0338-1130-03	00338113003	500 mL in 1 BAG (0338-1130-03)	500 ml	2003-06-19	0000-00-00	No	No	Current
0338-1130-04	00338113004	1000 mL in 1 BAG (0338-1130-04)	1000 ml	2003-06-19	0000-00-00	No	No	Current
0338-1130-06	00338113006	2000 mL in 1 BAG (0338-1130-06)	2000 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