Protamine Sulfate

Product NDC: 63323-229
11-digit product format: 633230229
Labeler code: 63323
Product ID: 63323-229_1e6b19d0-9376-4cec-9eef-fea441e0263e
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: 2000-10-18
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63323-229	63323-229-26	D	Discontinued by firm		2026-08-11

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 · 15 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	63323-229-26	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	63323-229-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	63323-229-26	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	63323-229-26	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	63323-229-26	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	63323-229-26	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	63323-229-26	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	63323-229-25	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	63323-229-26	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	63323-229-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	63323-229-26	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	63323-229-25	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	63323-229-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	63323-229-25	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	63323-229-25	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1796672	Internal RxNorm lookup
1796676	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
8df0a819-9e1a-44ce-97a6-3ea82c867d44	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63323-229-01	Protamine Sulfate	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	5	6
63323-229-05	Protamine Sulfate	25 in 1 TRAY	INJECTION, SOLUTION	25	6
63323-229-30	Protamine Sulfate	1 in 1 BOX	INJECTION, SOLUTION	1	6
63323-229-30	Protamine Sulfate	25 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	25	6
63323-229-41	Protamine Sulfate	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	5	5
63323-229-94	Protamine Sulfate	25 in 1 TRAY	INJECTION, SOLUTION	25	5
63323-229-95	Protamine Sulfate	1 in 1 BOX	INJECTION, SOLUTION	1	5
63323-229-95	Protamine Sulfate	25 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	25	5
63323-229-15	Protamine Sulfate	25 in 1 TRAY	INJECTION, SOLUTION	25	4
63323-229-21	Protamine Sulfate	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	5	4
63323-229-26	Protamine Sulfate	10 in 1 TRAY	INJECTION, SOLUTION	10	4
63323-229-26	Protamine Sulfate	25 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	25	4
63323-229-35	Protamine Sulfate	1 in 1 BOX	INJECTION, SOLUTION	1	4
63323-229-35	Protamine Sulfate	25 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	25	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-229-01	ML - Milliliter	63323-229	b248cdf3-93bc-4a84-89e5-acea106e1a12	1	2024-10-04
63323-229-05	ML - Milliliter	63323-229	032fd5ba-1f3c-4e1d-81b9-3705c5841b05	1	2013-02-13
63323-229-15	ML - Milliliter	63323-229	2b208c91-45ce-470d-b2a9-437acb3c8b34	1	2014-06-03
63323-229-21	ML - Milliliter	63323-229	64344195-578b-4a40-87c9-ef9de67820bf	1	2019-08-06
63323-229-30	ML - Milliliter	63323-229	5ea5d8d6-1de7-4af5-8c1b-e0894a56e102	1	2013-02-13
63323-229-35	ML - Milliliter	63323-229	40a33f29-25b5-4fda-8cf5-4d72172bfde5	1	2014-06-03
63323-229-41	ML - Milliliter	63323-229	67a8c4b7-7114-4679-865f-5d31482ba3f3	1	2019-10-07
63323-229-94	ML - Milliliter	63323-229	9bb4f4fa-de32-40f2-84d9-2d9bb18aefa4	1	2014-07-02
63323-229-95	ML - Milliliter	63323-229	2b1c90ae-0261-4707-93c4-ade581e81109	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROTAMINE SULFATE	ACTIVE INGREDIENT	0DE9724IHC	PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
PROTAMINE	ACTIVE MOIETY	72G3UY6T4N	PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	2
PROTAMINE SULFATE	ACTIVE INGREDIENT	0DE9724IHC	PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
PROTAMINE SULFATE	ACTIVE INGREDIENT	0DE9724IHC	PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
PROTAMINE	ACTIVE MOIETY	72G3UY6T4N	PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
PROTAMINE	ACTIVE MOIETY	72G3UY6T4N	PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-229	PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6	Current NDC, Legacy NDC, 4 package rows	20250214_e1964129-33f4-4e4e-86e3-8e6a4e65bd83.zip
63323-229	PROTAMINE SULFATE (PROTAMINE SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	5	Current NDC, Legacy NDC, 4 package rows	20240208_8df0a819-9e1a-44ce-97a6-3ea82c867d44.zip
63323-229	PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4	Current NDC, Legacy NDC, 6 package rows	20240402_7a31fc4c-579f-45cc-9559-39cfad9a57b3.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
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 ndc (product): 63323-229
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 ndc (product): 63323-229
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 ndc (product): 63323-229

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
1796676	protamine sulfate 250 MG in 25 ML Injection	PSN	e1964129-33f4-4e4e-86e3-8e6a4e65bd83	6
1796672	protamine sulfate 50 MG in 5 ML Injection	PSN	e1964129-33f4-4e4e-86e3-8e6a4e65bd83	6
1796676	25 ML protamine sulfate (USP) 10 MG/ML Injection	SCD	e1964129-33f4-4e4e-86e3-8e6a4e65bd83	6
1796672	5 ML protamine sulfate (USP) 10 MG/ML Injection	SCD	e1964129-33f4-4e4e-86e3-8e6a4e65bd83	6
1796676	protamine sulfate 250 MG per 25 ML Injection	SY	e1964129-33f4-4e4e-86e3-8e6a4e65bd83	6
1796672	protamine sulfate 50 MG per 5 ML Injection	SY	e1964129-33f4-4e4e-86e3-8e6a4e65bd83	6
1796676	protamine sulfate 250 MG in 25 ML Injection	PSN	8df0a819-9e1a-44ce-97a6-3ea82c867d44	5
1796672	protamine sulfate 50 MG in 5 ML Injection	PSN	8df0a819-9e1a-44ce-97a6-3ea82c867d44	5
1796676	25 ML protamine sulfate (USP) 10 MG/ML Injection	SCD	8df0a819-9e1a-44ce-97a6-3ea82c867d44	5
1796672	5 ML protamine sulfate (USP) 10 MG/ML Injection	SCD	8df0a819-9e1a-44ce-97a6-3ea82c867d44	5
1796676	protamine sulfate 250 MG per 25 ML Injection	SY	8df0a819-9e1a-44ce-97a6-3ea82c867d44	5
1796672	protamine sulfate 50 MG per 5 ML Injection	SY	8df0a819-9e1a-44ce-97a6-3ea82c867d44	5
1796676	protamine sulfate 250 MG in 25 ML Injection	PSN	7a31fc4c-579f-45cc-9559-39cfad9a57b3	4
1796672	protamine sulfate 50 MG in 5 ML Injection	PSN	94d4f57f-940e-c0a8-e053-2a95a90ae3af	4
1796672	protamine sulfate 50 MG in 5 ML Injection	PSN	7a31fc4c-579f-45cc-9559-39cfad9a57b3	4
1796676	25 ML protamine sulfate (USP) 10 MG/ML Injection	SCD	7a31fc4c-579f-45cc-9559-39cfad9a57b3	4
1796672	5 ML protamine sulfate (USP) 10 MG/ML Injection	SCD	94d4f57f-940e-c0a8-e053-2a95a90ae3af	4
1796672	5 ML protamine sulfate (USP) 10 MG/ML Injection	SCD	7a31fc4c-579f-45cc-9559-39cfad9a57b3	4
1796676	protamine sulfate 250 MG per 25 ML Injection	SY	7a31fc4c-579f-45cc-9559-39cfad9a57b3	4
1796672	protamine sulfate 50 MG per 5 ML Injection	SY	7a31fc4c-579f-45cc-9559-39cfad9a57b3	4
1796672	protamine sulfate 50 MG per 5 ML Injection	SY	94d4f57f-940e-c0a8-e053-2a95a90ae3af	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-229-01	63323022901	5 mL in 1 VIAL, SINGLE-DOSE	5 ml					Historical
63323-229-05	63323022905	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-229-01)		2000-10-18	0000-00-00	No	No	Current
63323-229-15	63323022915	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-15) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-229-21)		2000-10-18	0000-00-00	No	No	Current
63323-229-21	63323022921	5 mL in 1 VIAL, SINGLE-DOSE	5 ml					Historical
63323-229-25	63323022925	10 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-25) > 25 mL in 1 VIAL, SINGLE-DOSE		2000-10-18	0000-00-00	No	No	Current
63323-229-26	63323022926	10 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-26) > 25 mL in 1 VIAL, SINGLE-DOSE		2000-10-18	0000-00-00	No	No	Current
63323-229-30	63323022930	1 VIAL, SINGLE-DOSE in 1 BOX (63323-229-30) / 25 mL in 1 VIAL, SINGLE-DOSE		2000-10-18	0000-00-00	No	No	Current
63323-229-35	63323022935	1 VIAL, SINGLE-DOSE in 1 BOX (63323-229-35) / 25 mL in 1 VIAL, SINGLE-DOSE		2000-10-18	0000-00-00	No	No	Current
63323-229-41	63323022941	5 mL in 1 VIAL, SINGLE-DOSE	5 ml					Historical
63323-229-94	63323022994	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-94) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-229-41)		2000-10-18	0000-00-00	No	No	Current
63323-229-95	63323022995	1 VIAL, SINGLE-DOSE in 1 BOX (63323-229-95) / 25 mL in 1 VIAL, SINGLE-DOSE		2000-10-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Protamine Sulfate Injection, USP	Fresenius Kabi USA, LLC	2025-02-05	HUMAN PRESCRIPTION DRUG LABEL	6
Protamine Sulfate Injection, USP	Fresenius Kabi USA, LLC	2024-03-18	HUMAN PRESCRIPTION DRUG LABEL	4
PROTAMINE SULFATE INJECTION, USP 50mg/5mL (10mg/mL) 5mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2024-01-22	HUMAN PRESCRIPTION DRUG LABEL	4
Protamine Sulfate Injection, USP	Fresenius Kabi USA, LLC	2024-01-18	HUMAN PRESCRIPTION DRUG LABEL	5