SINCALIDE

Product NDC: 63323-579
11-digit product format: 633230579
Labeler code: 63323
Product ID: 63323-579_7aa01e72-178a-4161-b41b-f05bc8eba1a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sincalide
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: NDA017697
Marketing category: NDA
Marketing start: 2023-04-01
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: SINCALIDE
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
bb5057da-8568-49b9-947d-fab7d8d8f257	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63323-579-01	SINCALIDE	5 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	5		3
63323-579-05	SINCALIDE	10 in 1 PACKAGE	INJECTION, POWDER, LYOPHILIZED,	10		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-579-01	EA - Each	63323-579	6dae431e-c79f-4283-8c6b-d0fae4feb60b	1	2023-06-06
63323-579-05	EA - Each	63323-579	d639c8ca-4661-4dae-8937-a7213621a946	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-579	SINCALIDE (SINCALIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]	3	Current NDC, 2 package rows	20240131_bb5057da-8568-49b9-947d-fab7d8d8f257.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 ndc (product): 63323-579
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

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
237982	sincalide 5 MCG Injection	PSN	bb5057da-8568-49b9-947d-fab7d8d8f257	3
237982	sincalide 0.005 MG Injection	SCD	bb5057da-8568-49b9-947d-fab7d8d8f257	3
237982	sincalide 5 MCG Injection	SY	bb5057da-8568-49b9-947d-fab7d8d8f257	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63323-579-01	63323057901	5 mL in 1 VIAL	5 ml				Historical
63323-579-05	63323057905	10 VIAL in 1 PACKAGE (63323-579-05) / 5 mL in 1 VIAL (63323-579-01)	10 vial	2023-04-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SINCALIDE	Fresenius Kabi USA, LLC \| Bracco Diagnostics Inc.	2024-01-26	HUMAN PRESCRIPTION DRUG LABEL	3