Piperacillin and Tazobactam

Product NDC: 63323-982
11-digit product format: 633230982
Labeler code: 63323
Product ID: 63323-982_0802b499-4d2a-43ad-8fea-ad80b6738a46
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Piperacillin and Tazobactam
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA203719
Marketing category: ANDA
Marketing start: 2018-05-18
Substance: PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength: 4; .5 g/20mL; g/20mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
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 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	TE codes	Approval date
A203719-001	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18
A203719-002	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18
A203719-003	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203719-001	AP
A203719-002	AP
A203719-003	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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203719-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203719-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203719-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203719-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203719-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203719-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203719-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203719-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203719-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203719-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203719-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203719-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203719-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203719-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203719-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203719-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203719-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203719-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203719-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203719-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203719-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203719-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203719-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203719-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203719-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203719-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203719-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203719-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203719-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203719-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203719-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203719-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203719-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203719-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203719-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203719-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203719-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203719-002	PIPERACILLIN AND TAZOBACTAM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203719-003	PIPERACILLIN AND TAZOBACTAM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203719-001	PIPERACILLIN AND TAZOBACTAM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	2018-05-18	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203719-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203719-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203719-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203719-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203719-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203719-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203719-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203719-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203719-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203719-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203719-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203719-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203719-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203719-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203719-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203719-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203719-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203719-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203719-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203719-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203719-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203719-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203719-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203719-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203719-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203719-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203719-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203719-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203719-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203719-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203719-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203719-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203719-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203719-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203719-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203719-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203719-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203719-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203719-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203719-001	AP	1	`301d65b070ca…`

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: Piperacillin and Tazobactam
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PIPERACILLIN SODIUM	4 g/20mL
TAZOBACTAM SODIUM	.5 g/20mL

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1659131	Internal RxNorm lookup
1659137	Internal RxNorm lookup
1659149	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
dc8208ea-a632-4291-a90b-2eba9a33bb40	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
a6bfe911-d09e-4049-bcde-a3213184a72c	Product name	8	20240501
61877847-a958-4874-a7cf-2bbeff51a37b	Product name	2	20180717
e0d9b1cf-1fe5-42a8-b30f-70b3a7bd8d22	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63323-982-21	Piperacillin and Tazobactam	20 mL in 1 VIAL, SINGLE-USE	INJECTION, POWDER, LYOPHILIZED,	20	6
63323-982-52	Piperacillin and Tazobactam	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10	6
63323-982-43	Piperacillin and Tazobactam	20 mL in 1 VIAL, SINGLE-USE	INJECTION, POWDER, LYOPHILIZED,	20	4
63323-982-54	Piperacillin and Tazobactam	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-982-21	EA - Each	63323-982	b96e9e40-fac3-4917-bf26-7df2e93306fd	1	2019-06-19
63323-982-43	EA - Each	63323-982	e80de3e5-ecff-4776-bb6c-a7c23c63a85c	1	2020-03-10
63323-982-52	EA - Each	63323-982	d7876eb2-f7f5-4e6b-b008-9b874aae96e8	1	2019-06-19
63323-982-54	EA - Each	63323-982	487fd9a9-44e2-4549-9108-1ead8149e29d	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-982	PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]	6	Current NDC, Legacy NDC, 2 package rows	20221104_dc8208ea-a632-4291-a90b-2eba9a33bb40.zip
63323-982	PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]	4	Current NDC, Legacy NDC, 2 package rows	20221029_1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Piperacillin and Tazobactam	PIPERACILLIN AND TAZOBACTAM	Fresenius Kabi USA, LLC	a798faf5-cd97-4e35-a700-94c372978c46	2025-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203719 application number: ANDA203719
Piperacillin and Tazobactam	PIPERACILLIN AND TAZOBACTAM	Fresenius Kabi USA, LLC	dc8208ea-a632-4291-a90b-2eba9a33bb40	2022-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203719 application number: ANDA203719 ndc (product): 63323-982
Piperacillin and Tazobactam	PIPERACILLIN AND TAZOBACTAM	Fresenius Kabi USA, LLC	b9bd733c-1176-42cb-b318-1223b7e48dcb	2021-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203719 application number: ANDA203719
Piperacillin and Tazobactam	PIPERACILLIN AND TAZOBACTAM	Fresenius Kabi USA, LLC	1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16	2021-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203719 application number: ANDA203719 ndc (product): 63323-982

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1659131	piperacillin / tazobactam 2.25 GM Injection	PSN	dc8208ea-a632-4291-a90b-2eba9a33bb40	6
1659137	piperacillin / tazobactam 3.375 GM Injection	PSN	dc8208ea-a632-4291-a90b-2eba9a33bb40	6
1659149	piperacillin / tazobactam 4.5 GM Injection	PSN	dc8208ea-a632-4291-a90b-2eba9a33bb40	6
1659131	piperacillin 2000 MG / tazobactam 250 MG Injection	SCD	dc8208ea-a632-4291-a90b-2eba9a33bb40	6
1659137	piperacillin 3000 MG / tazobactam 375 MG Injection	SCD	dc8208ea-a632-4291-a90b-2eba9a33bb40	6
1659149	piperacillin 4000 MG / tazobactam 500 MG Injection	SCD	dc8208ea-a632-4291-a90b-2eba9a33bb40	6
1659131	piperacillin (as piperacillin sodium) 2000 MG / tazobactam (as tazobactam sodium) 250 MG Injection	SY	dc8208ea-a632-4291-a90b-2eba9a33bb40	6
1659137	piperacillin (as piperacillin sodium) 3000 MG / tazobactam (as tazobactam sodium) 375 MG Injection	SY	dc8208ea-a632-4291-a90b-2eba9a33bb40	6
1659149	piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG Injection	SY	dc8208ea-a632-4291-a90b-2eba9a33bb40	6
1659131	piperacillin / tazobactam 2.25 GM Injection	SY	dc8208ea-a632-4291-a90b-2eba9a33bb40	6
1659137	piperacillin / tazobactam 3.375 GM Injection	SY	dc8208ea-a632-4291-a90b-2eba9a33bb40	6
1659149	piperacillin / tazobactam 4.5 GM Injection	SY	dc8208ea-a632-4291-a90b-2eba9a33bb40	6
1659131	piperacillin / tazobactam 2.25 GM Injection	PSN	1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16	4
1659137	piperacillin / tazobactam 3.375 GM Injection	PSN	1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16	4
1659149	piperacillin / tazobactam 4.5 GM Injection	PSN	1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16	4
1659131	piperacillin 2000 MG / tazobactam 250 MG Injection	SCD	1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16	4
1659137	piperacillin 3000 MG / tazobactam 375 MG Injection	SCD	1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16	4
1659149	piperacillin 4000 MG / tazobactam 500 MG Injection	SCD	1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16	4
1659131	piperacillin (as piperacillin sodium) 2000 MG / tazobactam (as tazobactam sodium) 250 MG Injection	SY	1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16	4
1659137	piperacillin (as piperacillin sodium) 3000 MG / tazobactam (as tazobactam sodium) 375 MG Injection	SY	1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16	4
1659149	piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG Injection	SY	1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16	4
1659131	piperacillin / tazobactam 2.25 GM Injection	SY	1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16	4
1659137	piperacillin / tazobactam 3.375 GM Injection	SY	1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16	4
1659149	piperacillin / tazobactam 4.5 GM Injection	SY	1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-982-21	63323098221	20 mL in 1 VIAL, SINGLE-USE	20 ml					Historical
63323-982-43	63323098243	20 mL in 1 VIAL, SINGLE-USE	20 ml					Historical
63323-982-52	63323098252	10 VIAL, SINGLE-USE in 1 CARTON (63323-982-52) / 20 mL in 1 VIAL, SINGLE-USE (63323-982-21)		2018-05-18	0000-00-00	No	No	Current
63323-982-54	63323098254	10 VIAL, SINGLE-USE in 1 CARTON (63323-982-54) / 20 mL in 1 VIAL, SINGLE-USE (63323-982-43)		2018-05-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Piperacillin and Tazobactam	Fresenius Kabi USA, LLC \| Haupt Pharma Latina S.r.l.	2022-10-27	HUMAN PRESCRIPTION DRUG LABEL	6
Piperacillin and Tazobactam	Fresenius Kabi USA, LLC \| Haupt Pharma Latina S.r.l.	2021-04-02	HUMAN PRESCRIPTION DRUG LABEL	4