Neostigmine Methylsulfate

Product NDC: 76045-383
11-digit product format: 760450383
Labeler code: 76045
Product ID: 76045-383_27e94d4f-f8d8-437a-a770-7020a9f8f61d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Neostigmine Methylsulfate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: NDA203629
Marketing category: NDA
Marketing start: 2018-09-18
Substance: NEOSTIGMINE METHYLSULFATE
Active strength: 1 mg/mL
Pharmacologic classes: Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N203629-001	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08
N203629-002	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08
N203629-003	NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N203629-003	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 4 · 123 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	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203629-002	NEOSTIGMINE METHYLSULFATE	10MG/10ML (1MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203629-003	NEOSTIGMINE METHYLSULFATE	3MG/3ML (1MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203629-001	NEOSTIGMINE METHYLSULFATE	5MG/10ML (0.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2015-01-08	`8072bd15b7f6…`

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	N203629-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203629-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203629-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203629-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203629-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203629-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203629-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203629-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203629-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203629-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203629-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203629-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203629-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203629-003	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203629-003	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203629-003	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203629-003	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203629-003	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203629-003	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203629-003	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203629-003	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203629-003	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203629-003	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203629-003	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203629-003	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203629-003	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203629-003	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203629-003	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Neostigmine Methylsulfate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NEOSTIGMINE METHYLSULFATE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
98IMH7M386	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2105413	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
b0b509c3-8dc8-48cc-b7a8-16b93ad706c6	Available on FDA.report

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
76045-383-13	Neostigmine Methylsulfate	1 in 1 BLISTER PACK	INJECTION, SOLUTION	1	16
76045-383-13	Neostigmine Methylsulfate	3 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	3	16
76045-383-30	Neostigmine Methylsulfate	10 in 1 CARTON	INJECTION, SOLUTION	10	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76045-383-13	ML - Milliliter	76045-383	1c271f0e-2ab6-4d8d-9a60-9da24f07b365	1	2019-06-19
76045-383-30	ML - Milliliter	76045-383	6ba107d2-c99d-42f9-aaf0-eab00c938bdc	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76045-383	NEOSTIGMINE METHYLSULFATE (NEOSTIGMINE METHYLSULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	16	Current NDC, Legacy NDC, 3 package rows	20240119_b0b509c3-8dc8-48cc-b7a8-16b93ad706c6.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Fresenius Kabi USA, LLC	d0e11e4c-41c3-4874-b567-579db655fba3	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203629 application number: NDA203629
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Fresenius Kabi USA, LLC	088f96eb-20b8-48f8-ac83-329f75a44ce1	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203629 application number: NDA203629
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Fresenius Kabi USA, LLC	b0b509c3-8dc8-48cc-b7a8-16b93ad706c6	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203629 application number: NDA203629 ndc (product): 76045-383
Neostigmine Methylsulfate	NEOSTIGMINE METHYLSULFATE	Fresenius Kabi USA, LLC	6448229c-e650-47ba-bb00-cba3604502c5	2022-12-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203629 application number: NDA203629

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
2105413	neostigmine methylsulfate 3 MG in 3 ML Prefilled Syringe	PSN	b0b509c3-8dc8-48cc-b7a8-16b93ad706c6	16
2105413	3 ML neostigmine methylsulfate 1 MG/ML Prefilled Syringe	SCD	b0b509c3-8dc8-48cc-b7a8-16b93ad706c6	16
2105413	neostigmine methylsulfate 3 MG per 3 ML Prefilled Syringe	SY	b0b509c3-8dc8-48cc-b7a8-16b93ad706c6	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76045-383-13	76045038313	1 in 1 BLISTER PACK						Historical
76045-383-30	76045038330	10 BLISTER PACK in 1 CARTON (76045-383-30) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-383-13) / 3 mL in 1 SYRINGE, GLASS	10 blister pack	2018-09-18	0000-00-00	No	No	Current