Nutricel Additive Solution - AS-3

Product NDC: 53157-101
11-digit product format: 531570101
Labeler code: 53157
Product ID: 53157-101_25edc224-0331-45f2-842d-cc2b9514a9da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CP2D/AS-3 Anticoagulant and Additive System
Dosage form: SOLUTION
Route: INTRAVENOUS
Labeler: Haemonetics Manufacturing Inc.
Application: BN820915
Marketing category: NDA
Marketing start: 2013-09-13
Marketing end: 0000-00-00
Substance: DEXTROSE; ADENINE
Active strength: 1 g/110mL; g/110mL
NDC exclude flag: E
Listing certified through: 2017-12-31
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	53157-101		I	Inactivated by FDA		2026-09-09
excluded package	package	53157-101	53157-101-99	I	Inactivated by FDA		2026-09-09

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 · 44 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	53157-101-99	`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	53157-101-99	`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	53157-101-99	`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	53157-101-99	`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	53157-101-99	`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	53157-101-99	`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	53157-101-99	`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	53157-101-99	`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	53157-101-99	`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	53157-101-99	`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	53157-101-99	`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	53157-101-99	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53157-101-99	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53157-101-99	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53157-101-99	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53157-101-99	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53157-101-99	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53157-101-99	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53157-101-99	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53157-101-99	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53157-101-99	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53157-101-99	`110d247fa046…`	`a55b01930146…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53157-101-99	2019-11-27	C162847	48780-1	9855d018-eace-cd31-e053-dbdaa90ab51a	CP2D/AS-3 Blood Collection and Sampling System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53157-101-97	Nutricel Additive Solution - AS-3	110 mL in 1 BAG	SOLUTION	110	1
53157-101-98	Nutricel Additive Solution - AS-3	3 in 1 POUCH	SOLUTION	3	1
53157-101-99	Nutricel Additive Solution - AS-3	8 in 1 BOX	SOLUTION	8	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ADENINE	ACTIVE INGREDIENT	JAC85A2161	NUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]	1
DEXTROSE	ACTIVE INGREDIENT	IY9XDZ35W2	NUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]	1
ADENINE	ACTIVE MOIETY	JAC85A2161	NUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]	1
DEXTROSE	ACTIVE MOIETY	IY9XDZ35W2	NUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	NUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	NUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]	1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	NUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	NUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53157-101	NUTRICEL ADDITIVE SOLUTION - CP2D (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION NUTRICEL ADDITIVE SOLUTION - AS-3 (CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM) SOLUTION [HAEMONETICS MANUFACTURING INC.]	1	Legacy NDC, 3 package rows	20140403_6ce6f3c2-bb14-4d5e-a3b1-ddaf1348e067.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leukotrap RC System	CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	4c0dec79-1648-1cfd-e063-6394a90a88cc	2026-07-03		Exact identifier application number: BN820915
Leukotrap WB System - CP2D	CP2D/AS-3 - ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	44a82ea8-69bf-f061-e063-6394a90af3da	2026-07-03		Exact identifier application number: BN820915
Leukotrap WB system - CP2D	CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	42ece7e1-1da1-7e5a-e063-6294a90ac803	2026-07-03		Exact identifier application number: BN820915
Leukotrap WB System - CP2D	CP2D/AS-3 - ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	44a7d200-13cb-c0b0-e063-6294a90aafad	2026-07-03		Exact identifier application number: BN820915
Leukotrap RC PL System	CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	54eab581-bc48-f9f0-e063-6394a90a4b93	2026-06-25		Exact identifier application number: BN820915
Leukotrap WB system - CP2D	CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	54fdf3cf-41df-af7d-e063-6294a90ab1e6	2026-06-24		Exact identifier application number: BN820915
Blood Collection System	CP2D/AS-3 TRIPLE WITH SAMPLING SYSTEM	GVS TM INC	54e8cfd2-f91b-8381-e063-6394a90a3f77	2026-06-23		Exact identifier application number: BN820915
Leukotrap RC PL System	CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	54e9a497-7a94-44c9-e063-6294a90a84da	2026-06-23		Exact identifier application number: BN820915
Leukotrap RC PL System	CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	54eb0462-cd00-4467-e063-6394a90aa371	2026-06-23		Exact identifier application number: BN820915
Leukotrap RC System	CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	54eb3c81-5cc8-03c4-e063-6294a90a2065	2026-06-23		Exact identifier application number: BN820915
Leukotrap RC System	CP2D/AS-3 ANTICOAGULANT AND ADDITIVE SYSTEM	GVS TM INC	54ebb700-3bcf-d0e3-e063-6394a90a57c8	2026-06-23		Exact identifier application number: BN820915
AS-3	AS-3	GVS TM INC	3dfa3397-fc13-4659-e063-6394a90a5abc	2025-11-06	Warnings	Exact identifier application number: BN820915
CP2D	CP2D	GVS TM INC	3fa2e438-2ff0-a2df-e063-6394a90ac7b5	2025-11-06	Warnings	Exact identifier application number: BN820915

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JAC85A2161	ADENINE	73-24-5	ADENINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53157-101-97	53157010197	110 mL in 1 BAG	110 ml	Historical
53157-101-98	53157010198	3 in 1 POUCH		Historical
53157-101-99	53157010199	8 in 1 BOX		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CP2D/AS-3 Blood Collection and Sampling System	Haemonetics Manufacturing Inc.	2013-09-13	HUMAN PRESCRIPTION DRUG LABEL	1