Zosyn

Product NDC: 0338-9636
Requested package NDC: 0338-9636-24
11-digit product format: 003389636
Labeler code: 0338
Product ID: 0338-9636_d44ebbea-a212-4060-a50b-e7fab8e70ff6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: piperacillin sodium and tazobactam sodium
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: NDA050750
Marketing category: NDA
Marketing start: 2023-04-01
Substance: PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength: 3; .375 g/50mL; g/50mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N050750-001	ZOSYN IN PLASTIC CONTAINER	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 40MG BASE/ML;EQ 5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24
N050750-002	ZOSYN IN PLASTIC CONTAINER	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 60MG BASE/ML;EQ 7.5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24
N050750-003	ZOSYN IN PLASTIC CONTAINER	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 4GM BASE/100ML;EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050750-001	ZOSYN IN PLASTIC CONTAINER	EQ 40MG BASE/ML;EQ 5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050750-002	ZOSYN IN PLASTIC CONTAINER	EQ 60MG BASE/ML;EQ 7.5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050750-003	ZOSYN IN PLASTIC CONTAINER	EQ 4GM BASE/100ML;EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050750-001	ZOSYN IN PLASTIC CONTAINER	EQ 40MG BASE/ML;EQ 5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050750-002	ZOSYN IN PLASTIC CONTAINER	EQ 60MG BASE/ML;EQ 7.5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050750-003	ZOSYN IN PLASTIC CONTAINER	EQ 4GM BASE/100ML;EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050750-001	ZOSYN IN PLASTIC CONTAINER	EQ 40MG BASE/ML;EQ 5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050750-002	ZOSYN IN PLASTIC CONTAINER	EQ 60MG BASE/ML;EQ 7.5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050750-003	ZOSYN IN PLASTIC CONTAINER	EQ 4GM BASE/100ML;EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050750-001	ZOSYN IN PLASTIC CONTAINER	EQ 40MG BASE/ML;EQ 5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050750-002	ZOSYN IN PLASTIC CONTAINER	EQ 60MG BASE/ML;EQ 7.5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050750-003	ZOSYN IN PLASTIC CONTAINER	EQ 4GM BASE/100ML;EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050750-001	ZOSYN IN PLASTIC CONTAINER	EQ 40MG BASE/ML;EQ 5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050750-002	ZOSYN IN PLASTIC CONTAINER	EQ 60MG BASE/ML;EQ 7.5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050750-003	ZOSYN IN PLASTIC CONTAINER	EQ 4GM BASE/100ML;EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050750-001	ZOSYN IN PLASTIC CONTAINER	EQ 40MG BASE/ML;EQ 5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050750-002	ZOSYN IN PLASTIC CONTAINER	EQ 60MG BASE/ML;EQ 7.5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050750-003	ZOSYN IN PLASTIC CONTAINER	EQ 4GM BASE/100ML;EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050750-001	ZOSYN IN PLASTIC CONTAINER	EQ 40MG BASE/ML;EQ 5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050750-002	ZOSYN IN PLASTIC CONTAINER	EQ 60MG BASE/ML;EQ 7.5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050750-003	ZOSYN IN PLASTIC CONTAINER	EQ 4GM BASE/100ML;EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050750-001	ZOSYN IN PLASTIC CONTAINER	EQ 40MG BASE/ML;EQ 5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050750-002	ZOSYN IN PLASTIC CONTAINER	EQ 60MG BASE/ML;EQ 7.5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050750-003	ZOSYN IN PLASTIC CONTAINER	EQ 4GM BASE/100ML;EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050750-001	ZOSYN IN PLASTIC CONTAINER	EQ 40MG BASE/ML;EQ 5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050750-002	ZOSYN IN PLASTIC CONTAINER	EQ 60MG BASE/ML;EQ 7.5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050750-003	ZOSYN IN PLASTIC CONTAINER	EQ 4GM BASE/100ML;EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050750-001	ZOSYN IN PLASTIC CONTAINER	EQ 40MG BASE/ML;EQ 5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050750-002	ZOSYN IN PLASTIC CONTAINER	EQ 60MG BASE/ML;EQ 7.5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050750-003	ZOSYN IN PLASTIC CONTAINER	EQ 4GM BASE/100ML;EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050750-001	ZOSYN IN PLASTIC CONTAINER	EQ 40MG BASE/ML;EQ 5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050750-002	ZOSYN IN PLASTIC CONTAINER	EQ 60MG BASE/ML;EQ 7.5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050750-003	ZOSYN IN PLASTIC CONTAINER	EQ 4GM BASE/100ML;EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050750-001	ZOSYN IN PLASTIC CONTAINER	EQ 40MG BASE/ML;EQ 5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050750-002	ZOSYN IN PLASTIC CONTAINER	EQ 60MG BASE/ML;EQ 7.5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050750-003	ZOSYN IN PLASTIC CONTAINER	EQ 4GM BASE/100ML;EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050750-001	ZOSYN IN PLASTIC CONTAINER	EQ 40MG BASE/ML;EQ 5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050750-002	ZOSYN IN PLASTIC CONTAINER	EQ 60MG BASE/ML;EQ 7.5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050750-003	ZOSYN IN PLASTIC CONTAINER	EQ 4GM BASE/100ML;EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050750-001	ZOSYN IN PLASTIC CONTAINER	EQ 40MG BASE/ML;EQ 5MG BASE/ML	INJECTABLE / INJECTION	RLD, RS	1998-02-24	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 228 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050750-001	6900184	2023-04-14	U-282	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050750-001	7915229	2023-04-14		Drug product	2011-04-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050750-001	8133883	2023-04-14	U-282	Drug product	2012-04-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050750-002	6900184	2023-04-14	U-282	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050750-002	7915229	2023-04-14		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050750-002	8133883	2023-04-14	U-282	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050750-003	6900184	2023-04-14	U-282	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050750-003	7915229	2023-04-14		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050750-003	8133883	2023-04-14	U-282	Drug product		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050750-001	6900184	2023-04-14	U-282	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050750-001	7915229	2023-04-14		Drug product	2011-04-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050750-001	8133883	2023-04-14	U-282	Drug product	2012-04-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050750-002	6900184	2023-04-14	U-282	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050750-002	7915229	2023-04-14		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050750-002	8133883	2023-04-14	U-282	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050750-003	6900184	2023-04-14	U-282	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050750-003	7915229	2023-04-14		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050750-003	8133883	2023-04-14	U-282	Drug product		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050750-001	6900184	2023-04-14	U-282	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050750-001	7915229	2023-04-14		Drug product	2011-04-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050750-001	8133883	2023-04-14	U-282	Drug product	2012-04-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050750-002	6900184	2023-04-14	U-282	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050750-002	7915229	2023-04-14		Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050750-002	8133883	2023-04-14	U-282	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050750-003	6900184	2023-04-14	U-282	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050750-003	7915229	2023-04-14		Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050750-003	8133883	2023-04-14	U-282	Drug product		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050750-001	6207661	2019-02-22		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050750-001	6900184	2023-04-14	U-282	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050750-001	7915229	2023-04-14		Drug product	2011-04-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050750-001	8133883	2023-04-14	U-282	Drug product	2012-04-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050750-002	6207661	2019-02-22		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050750-002	6900184	2023-04-14	U-282	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050750-002	7915229	2023-04-14		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050750-002	8133883	2023-04-14	U-282	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050750-003	6207661	2019-02-22		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050750-003	6900184	2023-04-14	U-282	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050750-003	7915229	2023-04-14		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050750-003	8133883	2023-04-14	U-282	Drug product		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050750-001	6900184	2023-04-14	U-282	Drug product		`bb7c543d1eb4…`

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: Zosyn
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PIPERACILLIN SODIUM	3 g/50mL
TAZOBACTAM SODIUM	.375 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
M98T69Q7HP	Internal UNII lookup
UXA545ABTT	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1659131	Internal RxNorm lookup
1659134	Internal RxNorm lookup
1659137	Internal RxNorm lookup
1659139	Internal RxNorm lookup
1659149	Internal RxNorm lookup
1659151	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
8db6bd91-2106-4bfd-8cc8-38aaf1e18d17	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5fa255cf-091e-4504-8ebf-eef4259776e8	Product name	1	20260112
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
a6bfe911-d09e-4049-bcde-a3213184a72c	Product name	8	20240501
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
61877847-a958-4874-a7cf-2bbeff51a37b	Product name	2	20180717
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
e0d9b1cf-1fe5-42a8-b30f-70b3a7bd8d22	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0338-9636-24	2024-01-30	C162847	48780-1	1030e365-284f-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use ZOSYN safely and effectively. See full prescribing information for ZOSYN. ZOSYN ® (piperacillin and tazobactam) injection, for intravenous use Initial U.S. Approval: 1993
0338-9636-24	2024-01-30	C162847	48780-1	1030e365-284f-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use ZOSYN safely and effectively. See full prescribing information for ZOSYN. ZOSYN (piperacillin and tazobactam) injection, for intravenous use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-9636-01	Zosyn	50 mL in 1 BAG	INJECTION, SOLUTION	50		6
0338-9636-24	Zosyn	24 in 1 CARTON	INJECTION, SOLUTION	24		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-9636-01	ML - Milliliter	0338-9636	2cb2857f-9567-431d-9d83-a62294fc7fbc	1	2023-05-05
0338-9636-24	ML - Milliliter	0338-9636	598dbf5a-6f28-4dd5-bc5f-cb0e60c6c93a	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-9636	ZOSYN (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	5	Current NDC, 2 package rows	20241211_8db6bd91-2106-4bfd-8cc8-38aaf1e18d17.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zosyn	PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM	Baxter Healthcare Corporation	8db6bd91-2106-4bfd-8cc8-38aaf1e18d17	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050750 application number: NDA050750 ndc (package): 0338-9636-24 ndc (product): 0338-9636 ndc11 (package): 00338963624
Zosyn in Galaxy Containers	TAZOBACTAM SODIUM AND PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	8ab9d90d-2f7f-4599-a44f-3d0a8f8ab623	2023-03-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050750 application number: NDA050750

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M98T69Q7HP	PIPERACILLIN SODIUM	59703-84-3	PIPERACILLIN SODIUM
UXA545ABTT	TAZOBACTAM SODIUM	89785-84-2	TAZOBACTAM SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0338-9636-24	00338963624	24 BAG in 1 CARTON (0338-9636-24) / 50 mL in 1 BAG (0338-9636-01)	24 bag	2023-04-01	No	No	Current