KINEVAC

Product NDC: 0270-0556
11-digit product format: 002700556
Labeler code: 0270
Product ID: 0270-0556_0d2aa8b3-2d00-f50a-c4cc-92748288e6aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sincalide
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Bracco Diagnostics Inc.
Application: NDA017697
Marketing category: NDA
Marketing start: 1976-07-21
Substance: SINCALIDE
Active strength: 5 ug/5mL
Pharmacologic classes: Cholecystokinin Analog [EPC], Cholecystokinin [CS]
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 1.

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
N017697-001	KINEVAC	SINCALIDE	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017697-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017697-001	KINEVAC	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017697-001	KINEVAC	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017697-001	KINEVAC	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017697-001	KINEVAC	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017697-001	KINEVAC	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017697-001	KINEVAC	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017697-001	KINEVAC	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017697-001	KINEVAC	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017697-001	KINEVAC	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017697-001	KINEVAC	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017697-001	KINEVAC	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017697-001	KINEVAC	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017697-001	KINEVAC	0.005MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017697-001	KINEVAC	0.005MG/VIAL	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017697-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017697-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017697-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017697-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017697-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017697-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017697-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017697-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017697-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017697-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017697-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017697-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017697-001	AP	1	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017697-001	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017697-001	6803046	2022-08-16	Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017697-001	6803046	2022-08-16	Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017697-001	6803046	2022-08-16	Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017697-001	6803046	2022-08-16	Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017697-001	6803046	2022-08-16	Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017697-001	6803046	2022-08-16	Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017697-001	6803046	2022-08-16	Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017697-001	6803046	2022-08-16	Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017697-001	6803046	2022-08-16	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017697-001	6803046	2022-08-16	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017697-001	6803046	2022-08-16	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017697-001	6803046	2022-08-16	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017697-001	6803046	2022-08-16	Drug product	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N017697-001	6803046	2022-08-16	Drug product	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017697-001	6803046	2022-08-16	Drug product	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017697-001	6803046	2022-08-16	Drug product	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017697-001	6803046	2022-08-16	Drug product	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017697-001	6803046	2022-08-16	Drug product	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: KINEVAC
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SINCALIDE	5 ug/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
M03GIQ7Z6P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
208236	Internal RxNorm lookup
237982	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
1408aabb-6982-48e5-ae9f-504ec43b0003	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
957ff0e8-12af-4796-85ed-d1e36ea7fdc0	Product name	1	20230912
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0270-0556-15	KINEVAC	5 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	5		13
0270-0556-15	KINEVAC	10 in 1 PACKAGE	INJECTION, POWDER, LYOPHILIZED,	10		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0270-0556-15	EA - Each	0270-0556	aa54873e-1d0f-4110-a42d-b8d9cae52f5f	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Sincalide	ACTIVE INGREDIENT	M03GIQ7Z6P	KINEVAC (SINCALIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC.]	4
Sincalide	ACTIVE MOIETY	M03GIQ7Z6P	KINEVAC (SINCALIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC.]	4
arginine hydrochloride	INACTIVE INGREDIENT	F7LTH1E20Y	KINEVAC (SINCALIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC.]	4
lysine hydrochloride	INACTIVE INGREDIENT	JNJ23Q2COM	KINEVAC (SINCALIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC.]	4
mannitol	INACTIVE INGREDIENT	3OWL53L36A	KINEVAC (SINCALIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC.]	4
methionine	INACTIVE INGREDIENT	AE28F7PNPL	KINEVAC (SINCALIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC.]	4
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	KINEVAC (SINCALIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC.]	4
potassium phosphate, dibasic	INACTIVE INGREDIENT	CI71S98N1Z	KINEVAC (SINCALIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC.]	4
sodium metabisulfite	INACTIVE INGREDIENT	4VON5FNS3C	KINEVAC (SINCALIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0270-0556	KINEVAC (SINCALIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRACCO DIAGNOSTICS INC.]	13	Current NDC, Legacy NDC, 2 package rows	20231020_1408aabb-6982-48e5-ae9f-504ec43b0003.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
SINCALIDE	SINCALIDE	Fresenius Kabi USA, LLC	bb5057da-8568-49b9-947d-fab7d8d8f257	2024-01-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017697 application number: NDA017697
KINEVAC	SINCALIDE	Bracco Diagnostics Inc.	1408aabb-6982-48e5-ae9f-504ec43b0003	2023-10-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017697 application number: NDA017697 ndc (product): 0270-0556

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M03GIQ7Z6P	SINCALIDE	25126-32-3	SINCALIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
208236	KINEVAC 5 MCG Injection	PSN	1408aabb-6982-48e5-ae9f-504ec43b0003	13
237982	sincalide 5 MCG Injection	PSN	1408aabb-6982-48e5-ae9f-504ec43b0003	13
208236	sincalide 0.005 MG Injection [Kinevac]	SBD	1408aabb-6982-48e5-ae9f-504ec43b0003	13
237982	sincalide 0.005 MG Injection	SCD	1408aabb-6982-48e5-ae9f-504ec43b0003	13
208236	Kinevac 0.005 MG Injection	SY	1408aabb-6982-48e5-ae9f-504ec43b0003	13
208236	Kinevac 5 MCG Injection	SY	1408aabb-6982-48e5-ae9f-504ec43b0003	13
237982	sincalide 5 MCG Injection	SY	1408aabb-6982-48e5-ae9f-504ec43b0003	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0270-0556-15	00270055615	10 VIAL in 1 PACKAGE (0270-0556-15) / 5 mL in 1 VIAL	10 vial	1976-07-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KINEVAC	Bracco Diagnostics Inc. \| Jubilant HollisterStier LLC \| Fresenius Kabi USA, LLC \| Bachem AG	2023-10-18	HUMAN PRESCRIPTION DRUG LABEL	13