Home NDC 67066-007 ChiRhoStim 40
Product NDC 67066-007
11-digit product format 670660007
Labeler code 67066
Product ID 67066-007_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 2007-06-21
Substance SECRETIN HUMAN
Active strength 40 ug/10mL
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 Product TE source text 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 40
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SECRETIN HUMAN 40 ug/10mL
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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67066-007-01 ChiRhoStim 40 10 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 10 20251008
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 67066-007 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.
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 67066-007-01 67066000701 10 mL in 1 VIAL, SINGLE-USE (67066-007-01) 10 ml 2007-06-21 0000-00-00 No No Current