Neostigmine Methylsulfate

Product NDC: 0641-6240
11-digit product format: 006416240
Labeler code: 0641
Product ID: 0641-6240_521e4ee9-7150-4513-b9d5-7fc5cc9efd0a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Neostigmine Methylsulfate
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA216206
Marketing category: ANDA
Marketing start: 2022-07-13
Marketing end: 0000-00-00
Substance: NEOSTIGMINE METHYLSULFATE
Active strength: 1 mg/mL
Pharmacologic classes: Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0641-6240		D	Discontinued by firm		2026-08-11
excluded package	package	0641-6240	0641-6240-10	D	Discontinued by firm		2026-08-11

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
A216206-001	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS			2022-07-13

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	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-07-13	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216206-001	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS		2022-07-13	`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	A216206-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216206-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216206-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216206-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216206-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216206-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216206-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216206-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216206-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216206-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216206-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216206-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216206-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216206-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216206-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216206-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216206-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216206-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216206-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216206-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216206-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216206-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216206-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216206-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216206-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216206-001	AP	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6240-10	ML - Milliliter	0641-6240	16cc5306-de69-4139-89bc-3af177de364c	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6240	NEOSTIGMINE METHYLSULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]	2	Legacy NDC	20240410_9afefbea-ea4a-48c5-ba51-42ece652eb7d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98IMH7M386	NEOSTIGMINE METHYLSULFATE	51-60-5	NEOSTIGMINE METHYLSULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0641-6240-10	00641624010	10 SYRINGE, PLASTIC in 1 CARTON (0641-6240-10) > 3 mL in 1 SYRINGE, PLASTIC	2022-07-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Neostigmine Methylsulfate	Hikma Pharmaceuticals USA Inc.	2024-04-09	HUMAN PRESCRIPTION DRUG LABEL	2