Home NDC 31722-016 Glycopyrrolate
Product NDC 31722-016
11-digit product format 317220016
Labeler code 31722
Product ID 31722-016_e3b10753-2b28-5dd9-e053-2995a90a8687
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Glycopyrrolate
Dosage form SOLUTION
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA213698
Marketing category ANDA
Marketing start 2022-07-05
Substance GLYCOPYRROLATE
Active strength 1 mg/5mL
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
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 A213698-001 GLYCOPYRROLATE GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213698-001 AA
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 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213698-001 GLYCOPYRROLATE 1MG/5ML SOLUTION / ORAL AA 2022-07-05 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Glycopyrrolate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCOPYRROLATE 1 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V92SO9WP2I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 999961 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 31722-016-47 Glycopyrrolate 473 mL in 1 BOTTLE SOLUTION 473 1 31722-016-47 Glycopyrrolate 1 in 1 CARTON SOLUTION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-016 GLYCOPYRROLATE SOLUTION [CAMBER PHARMACEUTICALS, INC.] 1 Current NDC, Legacy NDC, 2 package rows 20220715_4741be85-3abb-4545-aba9-281f64d210ec.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 · 3 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 31722-016-47 31722001647 1 BOTTLE in 1 CARTON (31722-016-47) / 473 mL in 1 BOTTLE 1 bottle 2022-07-05 0000-00-00 No No Current