ChiRhoStim

Product NDC: 67066-005
11-digit product format: 670660005
Labeler code: 67066
Product ID: 67066-005_40a8cfc0-9a1b-f924-e063-6294a90afce0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Human Secretin
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: ChiRhoClin, Inc.
Application: NDA021256
Marketing category: NDA
Marketing start: 2004-08-01
Substance: SECRETIN HUMAN
Active strength: 16 ug/8mL
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021256-001	CHIRHOSTIM	SECRETIN SYNTHETIC HUMAN	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS		RLD, RS	2004-04-09
N021256-002	CHIRHOSTIM	SECRETIN SYNTHETIC HUMAN	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS		RLD	2007-06-21

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 3 · 86 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	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021256-001	CHIRHOSTIM	16MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD, RS	2004-04-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021256-002	CHIRHOSTIM	40MCG/VIAL	FOR SOLUTION / INTRAVENOUS	RLD	2007-06-21	`74a2ff9319b5…`

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: ChiRhoStim
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SECRETIN HUMAN	16 ug/8mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
A0426J905J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
727488	Internal RxNorm lookup
727492	Internal RxNorm lookup
727494	Internal RxNorm lookup
727496	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
b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67066-005-01	ChiRhoStim	8 mL in 1 VIAL, SINGLE-USE	INJECTION, POWDER, LYOPHILIZED,	8		20251008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67066-005-01	EA - Each	67066-005	61070046-b612-4c1f-b1be-949a9db761f9	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Secretin human	ACTIVE INGREDIENT	A0426J905J	CHIRHOSTIM (SECRETIN HUMAN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION FOR INTRAVENOUS USE [CHIRHOCLIN, INC]	1
Secretin human	ACTIVE MOIETY	A0426J905J	CHIRHOSTIM (SECRETIN HUMAN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION FOR INTRAVENOUS USE [CHIRHOCLIN, INC]	1
L-cysteine hydrochloride	INACTIVE INGREDIENT		CHIRHOSTIM (SECRETIN HUMAN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION FOR INTRAVENOUS USE [CHIRHOCLIN, INC]	1
mannitol	INACTIVE INGREDIENT	3OWL53L36A	CHIRHOSTIM (SECRETIN HUMAN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION FOR INTRAVENOUS USE [CHIRHOCLIN, INC]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	CHIRHOSTIM (SECRETIN HUMAN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION FOR INTRAVENOUS USE [CHIRHOCLIN, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67066-005	CHIRHOSTIM (HUMAN SECRETIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CHIRHOSTIM 40 (HUMAN SECRETIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CHIRHOCLIN, INC.]	20250328	Current NDC, Legacy NDC, 1 package rows	20250412_b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ChiRhoStim	HUMAN SECRETIN	ChiRhoClin, Inc.	b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021256 application number: NDA021256 ndc (product): 67066-005

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
A0426J905J	SECRETIN HUMAN	108153-74-8	SECRETIN HUMAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
727492	ChiRhoStim 16 MCG Injection	PSN	b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd	20251008
727496	ChiRhoStim 40 MCG Injection	PSN	b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd	20251008
727488	secretin human, synthetic 16 MCG Injection	PSN	b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd	20251008
727494	secretin human, synthetic 40 MCG Injection	PSN	b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd	20251008
727492	secretin human, synthetic 0.016 MG Injection [Chirhostim]	SBD	b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd	20251008
727496	secretin human, synthetic 0.04 MG Injection [Chirhostim]	SBD	b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd	20251008
727488	secretin human, synthetic 0.016 MG Injection	SCD	b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd	20251008
727494	secretin human, synthetic 0.04 MG Injection	SCD	b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd	20251008
727492	Chirhostim (as the acetate) 16 MCG Injection	SY	b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd	20251008
727496	Chirhostim (as the acetate) 40 MCG Injection	SY	b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd	20251008
727492	Chirhostim 0.016 MG Injection	SY	b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd	20251008
727496	Chirhostim 0.04 MG Injection	SY	b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd	20251008
727488	secretin human, synthetic (as the acetate) 16 MCG Injection	SY	b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd	20251008
727494	secretin human, synthetic (as the acetate) 40 MCG Injection	SY	b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd	20251008

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67066-005-01	67066000501	8 mL in 1 VIAL, SINGLE-USE (67066-005-01)	8 ml	2004-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ChiRhoStim	ChiRhoClin, Inc. \| Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services	2025-10-08	HUMAN PRESCRIPTION DRUG LABEL	20251008