THAM

Product NDC: 0409-1593
11-digit product format: 004091593
Labeler code: 0409
Product ID: 0409-1593_c8c27324-37d9-4f12-abe7-bc3b5fbf9fe7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TROMETHAMINE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: NDA013025
Marketing category: NDA
Marketing start: 2020-06-24
Substance: TROMETHAMINE
Active strength: 3.6 g/100mL
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
N013025-001	THAM-E	POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982
N013025-002	THAM	TROMETHAMINE	18GM/500ML (3.6GM/100ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N013025-002	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	Source SHA-256
2026-08-18 06:07:40	2026-07	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N013025-002	THAM	18GM/500ML (3.6GM/100ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N013025-002	THAM	18GM/500ML (3.6GM/100ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013025-002	THAM	18GM/500ML (3.6GM/100ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N013025-002	THAM	18GM/500ML (3.6GM/100ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013025-002	THAM	18GM/500ML (3.6GM/100ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013025-002	THAM	18GM/500ML (3.6GM/100ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013025-002	THAM	18GM/500ML (3.6GM/100ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013025-002	THAM	18GM/500ML (3.6GM/100ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N013025-002	THAM	18GM/500ML (3.6GM/100ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION		RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N013025-002	THAM	18GM/500ML (3.6GM/100ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION		RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N013025-002	THAM	18GM/500ML (3.6GM/100ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION		RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N013025-002	THAM	18GM/500ML (3.6GM/100ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION		RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N013025-002	THAM	18GM/500ML (3.6GM/100ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION		RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N013025-002	THAM	18GM/500ML (3.6GM/100ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION		RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N013025-002	THAM	18GM/500ML (3.6GM/100ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION		RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N013025-002	THAM	18GM/500ML (3.6GM/100ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION		RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N013025-002	THAM	18GM/500ML (3.6GM/100ML)	SOLUTION / INJECTION		RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N013025-002	THAM	18GM/500ML (3.6GM/100ML)	SOLUTION / INJECTION		RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N013025-002	THAM	3.6GM/100ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N013025-001	THAM-E	370MG/VIAL;1.75GM/VIAL;36GM/VIAL	INJECTABLE / INJECTION		Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N013025-002	THAM	18GM/500ML (3.6GM/100ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION		RLD, RS, Approved before 1982	`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	N013025-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N013025-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N013025-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N013025-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N013025-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N013025-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N013025-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N013025-002	AP	1	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N013025-002	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: THAM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TROMETHAMINE	3.6 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
023C2WHX2V	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198412	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
4af52118-c12b-4ad5-30bb-959848357e8a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
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
0409-1593-04	THAM	6 in 1 CASE	INJECTION, SOLUTION	6		21
0409-1593-14	THAM	500 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	500		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-1593-04	ML - Milliliter	0409-1593	d3df7c42-e6a0-4f93-921d-201fd78806fc	1	2012-07-24
0409-1593-14	ML - Milliliter	0409-1593	65f09a6f-f67f-4f76-9ac4-0e2ee7ff50e8	1	2020-07-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TROMETHAMINE	ACTIVE INGREDIENT	023C2WHX2V	THAM (TROMETHAMINE) INJECTION, SOLUTION [HOSPIRA, INC.]	10
tromethamine	ACTIVE MOIETY	023C2WHX2V	THAM (TROMETHAMINE) INJECTION, SOLUTION [HOSPIRA, INC.]	10
Acetic Acid	INACTIVE INGREDIENT	Q40Q9N063P	THAM (TROMETHAMINE) INJECTION, SOLUTION [HOSPIRA, INC.]	10
Water	INACTIVE INGREDIENT	059QF0KO0R	THAM (TROMETHAMINE) INJECTION, SOLUTION [HOSPIRA, INC.]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-1593	THAM (TROMETHAMINE) INJECTION, SOLUTION [HOSPIRA, INC.]	20	Current NDC, Legacy NDC, 2 package rows	20241215_4af52118-c12b-4ad5-30bb-959848357e8a.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
THAM	TROMETHAMINE	Hospira, Inc.	4af52118-c12b-4ad5-30bb-959848357e8a	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 013025 application number: NDA013025 ndc (product): 0409-1593

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
023C2WHX2V	TROMETHAMINE	77-86-1	TROMETHAMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198412	THAM 36 MG/ML in 500 ML Injection	PSN	4af52118-c12b-4ad5-30bb-959848357e8a	21
198412	500 ML tromethamine 36 MG/ML Injection	SCD	4af52118-c12b-4ad5-30bb-959848357e8a	21
198412	tromethamine 18 GM per 500 ML Injection	SY	4af52118-c12b-4ad5-30bb-959848357e8a	21
198412	tromethamine 3.6 GM per 100 ML Injection	SY	4af52118-c12b-4ad5-30bb-959848357e8a	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-1593-04	00409159304	6 BOTTLE, GLASS in 1 CASE (0409-1593-04) / 500 mL in 1 BOTTLE, GLASS (0409-1593-14)		2020-06-24	0000-00-00	No	No	Current
0409-1593-14	00409159314	500 mL in 1 BOTTLE, GLASS	500 ml					Historical