Home NDC 70511-131 Sincalide
Product NDC 70511-131
11-digit product format 705110131
Labeler code 70511
Product ID 70511-131_f79a9ced-87d3-4e83-af8c-1451fcec4520
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sincalide
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler MAIA Pharmaceuticals, Inc.
Application NDA210850
Marketing category NDA
Marketing start 2022-11-25
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 N210850-001 SINCALIDE SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2022-11-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N210850-001 AP
Orange Book patents# Current patent rows page 1 of 1 · 9 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210850-001 11110063 2038-04-20 U-3481 Drug product 2022-12-02 N210850-001 11110063 2038-04-20 U-3482 Drug product 2022-12-02 N210850-001 11110063 2038-04-20 U-3483 Drug product 2022-12-02 N210850-001 11318100 2038-04-20 U-3477 Drug product 2022-12-02 N210850-001 11318100 2038-04-20 U-3478 Drug product 2022-12-02 N210850-001 11318100 2038-04-20 U-3479 Drug product 2022-12-02 N210850-001 11318100 2038-04-20 U-3480 Drug product 2022-12-02 N210850-001 11737983 2038-04-20 U-3482 Drug product 2023-09-25 N210850-001 11737983 2038-04-20 U-3689 Drug product 2023-09-25
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.
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 2026-02-19 14:30 UTC 2026-02 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2022-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2022-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2022-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2022-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2022-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2022-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2022-11-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2022-11-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2022-11-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2022-11-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2022-11-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2022-11-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2022-11-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-11-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-11-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-11-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-11-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-11-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-11-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-11-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-11-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-11-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS RLD, RS 2022-11-22 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N210850-001 SINCALIDE 0.005MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 2022-11-22 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 6 · 208 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210850-001 11110063 2038-04-20 U-3481 Drug product 2022-12-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210850-001 11110063 2038-04-20 U-3482 Drug product 2022-12-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210850-001 11110063 2038-04-20 U-3483 Drug product 2022-12-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210850-001 11318100 2038-04-20 U-3477 Drug product 2022-12-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210850-001 11318100 2038-04-20 U-3478 Drug product 2022-12-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210850-001 11318100 2038-04-20 U-3479 Drug product 2022-12-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210850-001 11318100 2038-04-20 U-3480 Drug product 2022-12-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210850-001 11737983 2038-04-20 U-3482 Drug product 2023-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210850-001 11737983 2038-04-20 U-3689 Drug product 2023-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210850-001 11110063 2038-04-20 U-3481 Drug product 2022-12-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210850-001 11110063 2038-04-20 U-3482 Drug product 2022-12-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210850-001 11110063 2038-04-20 U-3483 Drug product 2022-12-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210850-001 11318100 2038-04-20 U-3477 Drug product 2022-12-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210850-001 11318100 2038-04-20 U-3478 Drug product 2022-12-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210850-001 11318100 2038-04-20 U-3479 Drug product 2022-12-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210850-001 11318100 2038-04-20 U-3480 Drug product 2022-12-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210850-001 11737983 2038-04-20 U-3482 Drug product 2023-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210850-001 11737983 2038-04-20 U-3689 Drug product 2023-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210850-001 11110063 2038-04-20 U-3481 Drug product 2022-12-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210850-001 11110063 2038-04-20 U-3482 Drug product 2022-12-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210850-001 11110063 2038-04-20 U-3483 Drug product 2022-12-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210850-001 11318100 2038-04-20 U-3477 Drug product 2022-12-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210850-001 11318100 2038-04-20 U-3478 Drug product 2022-12-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210850-001 11318100 2038-04-20 U-3479 Drug product 2022-12-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210850-001 11318100 2038-04-20 U-3480 Drug product 2022-12-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210850-001 11737983 2038-04-20 U-3482 Drug product 2023-09-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210850-001 11737983 2038-04-20 U-3689 Drug product 2023-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210850-001 11110063 2038-04-20 U-3481 Drug product 2022-12-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210850-001 11110063 2038-04-20 U-3482 Drug product 2022-12-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210850-001 11110063 2038-04-20 U-3483 Drug product 2022-12-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210850-001 11318100 2038-04-20 U-3477 Drug product 2022-12-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210850-001 11318100 2038-04-20 U-3478 Drug product 2022-12-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210850-001 11318100 2038-04-20 U-3479 Drug product 2022-12-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210850-001 11318100 2038-04-20 U-3480 Drug product 2022-12-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210850-001 11737983 2038-04-20 U-3482 Drug product 2023-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210850-001 11737983 2038-04-20 U-3689 Drug product 2023-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210850-001 11110063 2038-04-20 U-3481 Drug product 2022-12-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210850-001 11110063 2038-04-20 U-3482 Drug product 2022-12-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210850-001 11110063 2038-04-20 U-3483 Drug product 2022-12-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210850-001 11318100 2038-04-20 U-3477 Drug product 2022-12-02 b8a1b40f171c…
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70511-131-05 Sincalide 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 4 70511-131-84 Sincalide 10 in 1 PACKAGE INJECTION, POWDER, LYOPHILIZED, 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70511-131 SINCALIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MAIA PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20231102_4149af34-7b3d-4200-9609-ea856b1d6aab.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70511-131-05 70511013105 5 mL in 1 VIAL 5 ml Historical 70511-131-84 70511013184 10 VIAL in 1 PACKAGE (70511-131-84) / 5 mL in 1 VIAL (70511-131-05) 10 vial 2022-11-25 0000-00-00 No No Current