Glycopyrrolate

Product NDC: 70860-781
11-digit product format: 708600781
Labeler code: 70860
Product ID: 70860-781_5a904fde-11d4-4df3-96a2-335d14f78372
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: glycopyrrolate
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Athenex Pharmaceutical Division, LLC.
Application: ANDA210083
Marketing category: ANDA
Marketing start: 2020-11-30
Marketing end: 0000-00-00
Substance: GLYCOPYRROLATE
Active strength: 0 mg/mL
Pharmacologic classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70860-781		D	Discontinued by firm	2026-08-17
excluded package	package	70860-781	70860-781-01	D	Discontinued by firm	2026-08-17
excluded package	package	70860-781	70860-781-02	D	Discontinued by firm	2026-08-17
excluded package	package	70860-781	70860-781-05	D	Discontinued by firm	2026-08-17
excluded package	package	70860-781	70860-781-20	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70860-781	70860-781-20	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70860-781	70860-781-20	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A210083-001	GLYCOPYRROLATE	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP		2020-02-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210083-001	AP

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
2026-08-18 06:07:40	2026-07	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210083-001	GLYCOPYRROLATE	0.2MG/ML	INJECTABLE / INJECTION	AP	2020-02-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210083-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210083-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210083-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210083-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210083-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210083-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210083-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210083-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210083-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210083-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210083-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210083-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210083-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210083-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210083-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210083-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210083-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210083-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210083-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210083-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210083-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210083-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210083-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210083-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210083-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210083-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210083-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210083-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210083-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210083-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210083-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210083-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210083-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210083-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210083-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210083-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210083-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210083-001	AP	1	`a50c72e98297…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70860-781-01	2024-03-03	GLYCOPYRROLATE INJECTION, USP
70860-781-02	2024-03-03	GLYCOPYRROLATE INJECTION, USP
70860-781-05	2024-03-03	GLYCOPYRROLATE INJECTION, USP
70860-781-20	2024-03-03	GLYCOPYRROLATE INJECTION, USP
70860-781-01	2024-01-30	GLYCOPYRROLATE INJECTION, USP
70860-781-02	2024-01-30	GLYCOPYRROLATE INJECTION, USP
70860-781-05	2024-01-30	GLYCOPYRROLATE INJECTION, USP
70860-781-20	2024-01-30	GLYCOPYRROLATE INJECTION, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70860-781-01	ML - Milliliter	70860-781	3834fb8e-055f-4691-8172-ad274c6ccb10	1	2023-12-05
70860-781-02	ML - Milliliter	70860-781	f47612e8-abfb-4e7d-8636-026aaa421298	1	2024-06-10
70860-781-05	ML - Milliliter	70860-781	a3581a63-b43f-4e23-948b-9d82e63631b9	1	2023-12-05
70860-781-20	ML - Milliliter	70860-781	4cd125ee-5483-4569-bf0d-d90eb9410246	1	2023-12-05
70860-781-41	ML - Milliliter	70860-781	9f56f1ac-c461-4f22-8397-e2b61f2f2926	1	2023-12-05
70860-781-42	ML - Milliliter	70860-781	64f7bd2d-9942-4ff6-a34b-2387bddb5313	1	2024-06-10
70860-781-43	ML - Milliliter	70860-781	107bddd2-06ff-4f1d-bc7f-979232582124	1	2023-12-05
70860-781-44	ML - Milliliter	70860-781	ed4b6784-37b3-4ece-a149-c6eb19263859	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70860-781	GLYCOPYRROLATE INJECTION, SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]	5	Legacy NDC	20250130_c444d63b-f394-4ae5-a74d-50105a406574.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Sagent Pharmaceuticals	55930f87-8964-43b1-b790-c1e6dd2602d2	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210083 application number: ANDA210083
Glycopyrrolate	GLYCOPYRROLATE	Henry Schein, Inc.	8b4d1798-c0a7-4661-99cd-1e9a23c16386	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210083 application number: ANDA210083

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70860-781-01	70860078101	25 VIAL in 1 CARTON (70860-781-01) > 1 mL in 1 VIAL (70860-781-41)	25 vial	2020-11-30	0000-00-00	No	No	Current
70860-781-02	70860078102	25 VIAL in 1 CARTON (70860-781-02) > 2 mL in 1 VIAL (70860-781-42)	25 vial	2020-11-30	0000-00-00	No	No	Current
70860-781-05	70860078105	25 VIAL in 1 CARTON (70860-781-05) > 5 mL in 1 VIAL (70860-781-43)	25 vial	2020-11-30	0000-00-00	No	No	Current
70860-781-20	70860078120	10 VIAL in 1 CARTON (70860-781-20) > 20 mL in 1 VIAL (70860-781-44)	10 vial	2020-11-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GLYCOPYRROLATE INJECTION, USP	Athenex Pharmaceutical Division, LLC.	2025-01-28	HUMAN PRESCRIPTION DRUG LABEL	5