Glycopyrrolate

Product NDC: 49884-042
11-digit product format: 498840042
Labeler code: 49884
Product ID: 49884-042_3492c9f9-7d9b-4943-a68c-5e269f056640
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glycopyrrolate
Dosage form: SOLUTION
Route: ORAL
Labeler: Par Health USA, LLC
Application: ANDA204438
Marketing category: ANDA
Marketing start: 2022-01-04
Substance: GLYCOPYRROLATE
Active strength: 1 mg/5mL
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
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 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
A204438-001	GLYCOPYRROLATE	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA		2021-08-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A204438-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204438-001	GLYCOPYRROLATE	1MG/5ML	SOLUTION / ORAL	AA	2021-08-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204438-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204438-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204438-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204438-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204438-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204438-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204438-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204438-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204438-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204438-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204438-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204438-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204438-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204438-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204438-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204438-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204438-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204438-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204438-001	AA	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204438-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204438-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204438-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204438-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204438-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204438-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204438-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204438-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204438-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204438-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204438-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204438-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204438-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204438-001	AA	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204438-001	PC	2022-07-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204438-001	PC	2022-07-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204438-001	PC	2022-07-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204438-001	PC	2022-07-03	`bb7c543d1eb4…`
2023-01-26 05:58 UTC	2023-01	A204438-001	PC	2022-07-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204438-001	PC	2022-07-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204438-001	PC	2022-07-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204438-001	PC	2022-07-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204438-001	PC	2022-07-03	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Glycopyrrolate
Listing expiration: 2027-12-31

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ff65c5d3-7ba9-4315-a884-199151eb45a5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
138c3de2-4b03-4255-92b5-f022482d81bc	Product name	4	20260113
4dc252b1-bb5f-8bb6-4fa8-f3a45efd810e	Product name	5	20250304
f58f10d3-5fa9-4c2e-9a6e-77029e9ed80b	Product name	1	20231002
76dcac30-469f-4f92-9c55-70950d209446	Product name	1	20230809
132196a6-5117-4b6e-a9dd-27f2793580c6	Product name	1	20230112
ac1f888b-a1db-4d2e-abbc-973f21c2ce1b	Product name	1	20220720
d84dd569-7bf0-1410-25eb-017ef37dd406	Product name	9	20210902
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9a	Product name	1	20210204
58b12de9-b891-41c7-9be6-ff47de5ec28b	Product name	1	20180828
9aff7b10-8e47-4b10-9a92-803440a37ce2	Product name	1	20180206
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1	Product name	1	20160616
fb29b8a9-c2d0-42bb-aea8-9bc2a87db75a	Product name	1	20151113
ab7ba50c-5a47-47e6-8dd6-fa32a52559f6	Product name	1	20151109
29ae08d1-069f-9822-4820-152d5dc67797	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49884-042-33	Glycopyrrolate	16 mL in 1 BOTTLE	SOLUTION	16		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-042-33	ML - Milliliter	49884-042	6549cc29-bf7f-446f-9d66-55cea2bea88d	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-042	GLYCOPYRROLATE SOLUTION [ENDO USA, INC.]	12	Current NDC, Legacy NDC, 1 package rows	20240913_ff65c5d3-7ba9-4315-a884-199151eb45a5.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Par Health USA, LLC	ff65c5d3-7ba9-4315-a884-199151eb45a5	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204438 application number: ANDA204438 ndc (product): 49884-042
Glycopyrrolate	GLYCOPYRROLATE	Precision Dose, Inc.	e58f860b-e955-4d71-a128-93bd3812b08d	2025-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204438 application number: ANDA204438
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	579d2499-6520-41fb-ae52-f3d8b9af8950	2024-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204438 application number: ANDA204438

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V92SO9WP2I	GLYCOPYRROLATE	51186-83-5	GLYCOPYRROLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
999961	glycopyrrolate 1 MG in 5 mL Oral Solution	PSN	579d2499-6520-41fb-ae52-f3d8b9af8950	101
999961	glycopyrrolate 0.2 MG/ML Oral Solution	SCD	579d2499-6520-41fb-ae52-f3d8b9af8950	101
999961	glycopyrrolate 1 MG per 5 ML Oral Solution	SY	579d2499-6520-41fb-ae52-f3d8b9af8950	101
999961	glycopyrrolate 1 MG in 5 mL Oral Solution	PSN	ff65c5d3-7ba9-4315-a884-199151eb45a5	15
999961	glycopyrrolate 0.2 MG/ML Oral Solution	SCD	ff65c5d3-7ba9-4315-a884-199151eb45a5	15
999961	glycopyrrolate 1 MG per 5 ML Oral Solution	SY	ff65c5d3-7ba9-4315-a884-199151eb45a5	15
999961	glycopyrrolate 1 MG in 5 mL Oral Solution	PSN	e58f860b-e955-4d71-a128-93bd3812b08d	3
999961	glycopyrrolate 0.2 MG/ML Oral Solution	SCD	e58f860b-e955-4d71-a128-93bd3812b08d	3
999961	glycopyrrolate 1 MG per 5 ML Oral Solution	SY	e58f860b-e955-4d71-a128-93bd3812b08d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-042-33	49884004233	16 mL in 1 BOTTLE (49884-042-33)	16 ml	2022-01-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glycopyrrolate	Par Health USA, LLC	2026-05-14	HUMAN PRESCRIPTION DRUG LABEL	15
Glycopyrrolate	Precision Dose, Inc.	2025-08-08	HUMAN PRESCRIPTION DRUG LABEL	3
Glycopyrrolate	Bryant Ranch Prepack	2024-01-12	HUMAN PRESCRIPTION DRUG LABEL	101