Home NDC 15955-318-01 GLYCOPYRROLATE
Product NDC 15955-318
Requested package NDC 15955-318-01
11-digit product format 159550318
Labeler code 15955
Product ID 15955-318_adf69aaa-e03b-419a-ac5b-e7b80cab3668
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name GLYCOPYRROLATE
Dosage form TABLET
Route ORAL
Labeler Alembic Labs LLC
Application ANDA203657
Marketing category ANDA
Marketing start 2012-10-19
Substance GLYCOPYRROLATE
Active strength 2 mg/1
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203657-001 GLYCOPYRROLATE GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 A203657-002 GLYCOPYRROLATE GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203657-001 GLYCOPYRROLATE 1MG TABLET / ORAL AA 2018-11-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203657-002 GLYCOPYRROLATE 2MG TABLET / ORAL AA 2018-11-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base GLYCOPYRROLATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCOPYRROLATE 2 mg/1
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197738 Internal RxNorm lookup 197739 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 15955-318-01 GLYCOPYRROLATE 100 in 1 BOTTLE, PLASTIC TABLET 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 15955-318 GLYCOPYRROLATE TABLET [ALEMBIC LABS LLC] 3 Current NDC, Legacy NDC, 1 package rows 20201210_db178372-51d2-4194-bbe2-da9acb1cfd53.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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 15955-318-01 15955031801 100 TABLET in 1 BOTTLE, PLASTIC (15955-318-01) 100 tablet 2012-10-19 0000-00-00 No No Current