General Surgery Kit

Manufacturer: Centurion Medical Products | Hospira Inc
Effective date: 2012-09-25
Label type: MEDICAL DEVICE
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:47:37

Label at a glance#

ProductGeneral Surgery Kit

Active ingredientBUPIVACAINE HYDROCHLORIDE

Label structure3 sections

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Bupivacaine hydrochloride is a white crystalline powder that is freely soluable in 95 percent ethanol, soluable in water and slightly soluable in chloroform or acetone. The pH of this solution is 5.5 (4.0 to 6.5) with sodium hydroxide and/or hydrochloric acid. Bupivacaine Hydrochloride is available in sterile, hyperbaric solution for subarachnoid injection. Bupivacaine Spinal does not contain preservatives.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NS-CARDIO-BS.jpgMM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bupivacaine.jpgMM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1724784	BUPivacaine HCl 0.75 % in 2 ML Injection	PSN	1
1724784	2 ML bupivacaine hydrochloride 7.5 MG/ML Injection	SCD	1
1724784	bupivacaine HCl 0.75 % per 2 ML Injection	SY	1
1724784	bupivacaine HCl 15 MG per 2 ML Injection	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BUPIVACAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	Code 128	(01)10653160000006	GTIN-14: 10653160000006 GTIN storage (14 digits): 10653160000006	NS-CARDIO-BS.jpg
Barcode	DataBar Limited	(01)00304093613018	GTIN-14: 00304093613018 GTIN-12: 304093613018 UPC-A: 304093613018 EAN-13: 0304093613018 GTIN storage (14 digits): 00304093613018	bupivacaine.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435	Product name	2	20250303
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
e3a99641-4540-4894-9108-00cab3c57b7e	Product name	1	20211207
5da98533-f072-406b-9e1b-6ac19eca9926	Product name	1	20210622
306b993e-3140-4823-ad5e-88b708f9d2ac	Product name	1	20210510
a831e694-3663-4a83-82be-6c309429f750	Product name	2	20200608
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0409-3613-01	General Surgery Kit	2 mL in 1 AMPULE	INJECTION, SOLUTION	2 mL	7.5 mg in 1mL	1
24840-1570-1	General Surgery Kit	1 in 1 PACKAGE, COMBINATION	KIT	1		1
24840-1570-2	General Surgery Kit	10 in 1 CASE	KIT	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-3613	GENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]	1	Current NDC, Legacy NDC	20120925_493569d1-291b-4d89-aa0f-17474d90aa09.zip
24840-1570	GENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS]	1	3 package rows	20120925_493569d1-291b-4d89-aa0f-17474d90aa09.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-3613-01	ML - Milliliter	0409-3613	4869d9ca-b987-42d1-9872-429244ef0558	1	2012-07-24
0409-3613-11	ML - Milliliter	0409-3613	76512ff1-df52-445e-b7b6-d5f70e45d7c3	1	2020-01-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BUPIVACAINE HYDROCHLORIDE	ACTIVE INGREDIENT	7TQO7W3VT8	1
BUPIVACAINE	ACTIVE MOIETY	Y8335394RO	1
ANHYDROUS DEXTROSE	INACTIVE INGREDIENT	5SL0G7R0OK	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

General Surgery Kit
Bupivacaine
BUPIVACAINE HYDROCHLORIDE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
ANHYDROUS DEXTROSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
24840-1570	24840-1570-1, 24840-1570-2
0409-3613	0409-3613-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BUPIVACAINE HYDROCHLORIDE	7TQO7W3VT8	ACTIB
SODIUM HYDROXIDE	55X04QC32I	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
ANHYDROUS DEXTROSE	5SL0G7R0OK	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / SUBARACHNOID	ADJ PH		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / SUBARACHNOID	ADJ PH		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / SUBARACHNOID	ADJ PH		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
ANHYDROUS DEXTROSE	ANHYDROUS DEXTROSE	5SL0G7R0OK	INJECTION, SOLUTION / INTRAVENOUS		3187 mg	Exact identifier — unii+dosage form 2 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / SUBARACHNOID	ADJ PH		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
ANHYDROUS DEXTROSE	ANHYDROUS DEXTROSE	5SL0G7R0OK	INJECTION, SOLUTION / INTRAVENOUS		3187 mg	Exact identifier — unii+dosage form 2 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071810-001	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP		1987-12-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071810-001	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 2 · 44 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
2026-10-15 13:18:30	2026-09	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071810-001	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / SPINAL	AP	1987-12-11	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A071810-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A071810-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071810-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071810-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071810-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071810-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071810-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071810-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071810-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071810-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071810-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071810-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071810-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071810-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071810-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071810-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071810-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071810-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071810-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071810-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071810-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071810-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071810-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071810-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071810-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071810-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071810-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071810-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071810-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071810-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071810-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071810-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071810-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071810-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071810-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071810-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071810-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071810-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071810-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071810-001	AP	1	`3a93d1ddd44b…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupivacaine Spinal	BUPIVACAINE HYDROCHLORIDE IN DEXTROSE	Hospira, Inc.	7a8d2539-4422-4312-0298-207ef1a2948e	2026-04-07	Warnings, Adverse reactions	Exact identifier ndc (package): 0409-3613-01 ndc (product): 0409-3613 ndc11 (package): 00409361301

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.