NEOSTIGMINE METHYLSULFATE

Product NDC: 75834-150
Requested package NDC: 75834-150-10
11-digit product format: 758340150
Labeler code: 75834
Product ID: 75834-150_2dcffb9b-454f-49a0-bb77-f43a8429687d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: neostigmine methylsulfate
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Nivagen Pharmaceuticals, Inc.
Application: ANDA212627
Marketing category: ANDA
Marketing start: 2022-11-21
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: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	75834-150	75834-150-10	I	Inactivated by FDA		2026-09-14

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A212627-001	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-11-03
A212627-002	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP		2022-11-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A212627-001	AP
A212627-002	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.

Product history page 1 of 2 · 54 observed 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
2026-09-14 22:38:34	2026-08	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212627-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212627-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	2022-11-03	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212627-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212627-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212627-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212627-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212627-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212627-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212627-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212627-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212627-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212627-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212627-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212627-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212627-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212627-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212627-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212627-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212627-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212627-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212627-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212627-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212627-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212627-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212627-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212627-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212627-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212627-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212627-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212627-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212627-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212627-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212627-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212627-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212627-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212627-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212627-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212627-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212627-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212627-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212627-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212627-002	AP	1	`a72a2bbeb626…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f58f10d3-5fa9-4c2e-9a6e-77029e9ed80b	Product name	1	20231002
6c2b16d0-96e9-444e-98c5-9883cd6eb72d	Product name	2	20230316
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
ad279e69-d021-f6bd-1150-2b55f23832d5	Product name	9	20211014
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
75834-150-01	NEOSTIGMINE METHYLSULFATE	1 in 1 CARTON	INJECTION	1	2
75834-150-01	NEOSTIGMINE METHYLSULFATE	10 mL in 1 VIAL, MULTI-DOSE	INJECTION	10	2
75834-150-10	NEOSTIGMINE METHYLSULFATE	10 in 1 PACKAGE	INJECTION	10	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75834-150	NEOSTIGMINE METHYLSULFATE INJECTION [NIVAGEN PHARMACEUTICALS, INC.]	2	Legacy NDC, 3 package rows	20221121_dd6ddfa4-eee7-4027-b96e-c8b7ff04c55f.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311935	neostigmine methylsulfate 0.5 MG/ML Injectable Solution	PSN	dd6ddfa4-eee7-4027-b96e-c8b7ff04c55f	2
311936	neostigmine methylsulfate 1 MG/ML Injectable Solution	PSN	dd6ddfa4-eee7-4027-b96e-c8b7ff04c55f	2
311935	neostigmine methylsulfate 0.5 MG/ML Injectable Solution	SCD	dd6ddfa4-eee7-4027-b96e-c8b7ff04c55f	2
311936	neostigmine methylsulfate 1 MG/ML Injectable Solution	SCD	dd6ddfa4-eee7-4027-b96e-c8b7ff04c55f	2
311935	neostigmine methylsulfate 0.5 MG/ML Injectable Solution	SY	dd6ddfa4-eee7-4027-b96e-c8b7ff04c55f	2
311936	neostigmine methylsulfate 1 MG/ML Injectable Solution	SY	dd6ddfa4-eee7-4027-b96e-c8b7ff04c55f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75834-150-10	75834015010	10 CARTON in 1 PACKAGE (75834-150-10) > 1 VIAL, MULTI-DOSE in 1 CARTON (75834-150-01) > 10 mL in 1 VIAL, MULTI-DOSE	10 carton	2022-11-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NEOSTIGMINE METHYLSULFATE	Nivagen Pharmaceuticals, Inc.	2022-11-17	Human Prescription Drug Label	2