Protamine Sulfate

Product NDC: 65219-646
11-digit product format: 652190646
Labeler code: 65219
Product ID: 65219-646_c76876da-b9a8-45d0-9278-7df3288d3a06
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PROTAMINE SULFATE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA089454
Marketing category: ANDA
Marketing start: 2025-03-28
Substance: PROTAMINE SULFATE
Active strength: 10 mg/mL
Pharmacologic classes: Heparin Binding Activity [MoA], Heparin Reversal Agent [EPC], Reversed Anticoagulation Activity [PE]
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 1.

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
A089454-001	PROTAMINE SULFATE	PROTAMINE SULFATE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS		RS	1987-04-07
A089454-002	PROTAMINE SULFATE	PROTAMINE SULFATE	250MG/25ML (10MG/ML)	SOLUTION / INTRAVENOUS		RS	1987-04-07

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089454-001	PROTAMINE SULFATE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RS	1987-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089454-002	PROTAMINE SULFATE	250MG/25ML (10MG/ML)	SOLUTION / INTRAVENOUS	RS	1987-04-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089454-001	PROTAMINE SULFATE	50MG/5ML (10MG/ML)	SOLUTION / INTRAVENOUS	RS	1987-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089454-002	PROTAMINE SULFATE	250MG/25ML (10MG/ML)	SOLUTION / INTRAVENOUS	RS	1987-04-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089454-001	PROTAMINE SULFATE	10MG/ML	INJECTABLE / INJECTION	RS	1987-04-07	`f41ea6bd6efb…`

Additional Listing Data#

Finished product: Yes
Brand name base: Protamine Sulfate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROTAMINE SULFATE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0DE9724IHC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1796672	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
c76876da-b9a8-45d0-9278-7df3288d3a06	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65219-646-02	Protamine Sulfate	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	5		1
65219-646-05	Protamine Sulfate	25 in 1 TRAY	INJECTION, SOLUTION	25		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65219-646	PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1	Current NDC, 2 package rows	20250515_c76876da-b9a8-45d0-9278-7df3288d3a06.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Protamine Sulfate	PROTAMINE SULFATE	Fresenius Kabi USA, LLC	c76876da-b9a8-45d0-9278-7df3288d3a06	2025-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089454 application number: ANDA089454 ndc (product): 65219-646
Protamine Sulfate	PROTAMINE SULFATE	Fresenius Kabi USA, LLC	e1964129-33f4-4e4e-86e3-8e6a4e65bd83	2025-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089454 application number: ANDA089454
Protamine Sulfate	PROTAMINE SULFATE	Fresenius Kabi USA, LLC	7a31fc4c-579f-45cc-9559-39cfad9a57b3	2024-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089454 application number: ANDA089454
PROTAMINE SULFATE	PROTAMINE SULFATE	HF Acquisition Co LLC, DBA HealthFirst	94d4f57f-940e-c0a8-e053-2a95a90ae3af	2024-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089454 application number: ANDA089454
Protamine Sulfate	PROTAMINE SULFATE	Fresenius Kabi USA, LLC	8df0a819-9e1a-44ce-97a6-3ea82c867d44	2024-01-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089454 application number: ANDA089454

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0DE9724IHC	PROTAMINE SULFATE	9009-65-8	PROTAMINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1796672	protamine sulfate 50 MG in 5 ML Injection	PSN	c76876da-b9a8-45d0-9278-7df3288d3a06	1
1796672	5 ML protamine sulfate (USP) 10 MG/ML Injection	SCD	c76876da-b9a8-45d0-9278-7df3288d3a06	1
1796672	protamine sulfate 50 MG per 5 ML Injection	SY	c76876da-b9a8-45d0-9278-7df3288d3a06	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
65219-646-02	65219064602	5 mL in 1 VIAL, SINGLE-DOSE	5 ml				Historical
65219-646-05	65219064605	25 VIAL, SINGLE-DOSE in 1 TRAY (65219-646-05) / 5 mL in 1 VIAL, SINGLE-DOSE (65219-646-02)		2025-03-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Protamine Sulfate Injection, USP	Fresenius Kabi USA, LLC	2025-04-29	HUMAN PRESCRIPTION DRUG LABEL	1