Neostigmine Methylsulfate

Product NDC: 63323-413
11-digit product format: 633230413
Labeler code: 63323
Product ID: 63323-413_1efedce1-b2c3-4652-a289-6ea596b039e2
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: 2015-01-08
Substance: NEOSTIGMINE METHYLSULFATE
Active strength: .5 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	.5 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311935	Internal RxNorm lookup
311936	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
d0e11e4c-41c3-4874-b567-579db655fba3	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
63323-413-01	Neostigmine Methylsulfate	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	4
63323-413-10	Neostigmine Methylsulfate	10 in 1 TRAY	INJECTION, SOLUTION	10	4
63323-413-36	Neostigmine Methylsulfate	10 in 1 TRAY	INJECTION, SOLUTION	10	3
63323-413-36	Neostigmine Methylsulfate	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-413-10	ML - Milliliter	63323-413	6a6ee13a-ac87-45ce-bdf7-6cbc53582771	1	2015-03-03
63323-413-36	ML - Milliliter	63323-413	259824c1-d243-4db2-a3e2-36e20fbbe8cd	1	2016-08-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NEOSTIGMINE METHYLSULFATE	ACTIVE INGREDIENT	98IMH7M386	NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
NEOSTIGMINE METHYLSULFATE	ACTIVE INGREDIENT	98IMH7M386	NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
NEOSTIGMINE	ACTIVE MOIETY	3982TWQ96G	NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
NEOSTIGMINE	ACTIVE MOIETY	3982TWQ96G	NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
PHENOL	INACTIVE INGREDIENT	339NCG44TV	NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
PHENOL	INACTIVE INGREDIENT	339NCG44TV	NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-413	NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20221217_6448229c-e650-47ba-bb00-cba3604502c5.zip
63323-413	NEOSTIGMINE METHYLSULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20241020_d0e11e4c-41c3-4874-b567-579db655fba3.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 ndc (product): 63323-413
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
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 ndc (product): 63323-413

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	6448229c-e650-47ba-bb00-cba3604502c5	4
311936	neostigmine methylsulfate 1 MG/ML Injectable Solution	PSN	6448229c-e650-47ba-bb00-cba3604502c5	4
311935	neostigmine methylsulfate 0.5 MG/ML Injectable Solution	SCD	6448229c-e650-47ba-bb00-cba3604502c5	4
311936	neostigmine methylsulfate 1 MG/ML Injectable Solution	SCD	6448229c-e650-47ba-bb00-cba3604502c5	4
311935	neostigmine methylsulfate 0.5 MG/ML Injectable Solution	SY	6448229c-e650-47ba-bb00-cba3604502c5	4
311936	neostigmine methylsulfate 1 MG/ML Injectable Solution	SY	6448229c-e650-47ba-bb00-cba3604502c5	4
311935	neostigmine methylsulfate 0.5 MG/ML Injectable Solution	PSN	d0e11e4c-41c3-4874-b567-579db655fba3	3
311936	neostigmine methylsulfate 1 MG/ML Injectable Solution	PSN	d0e11e4c-41c3-4874-b567-579db655fba3	3
311935	neostigmine methylsulfate 0.5 MG/ML Injectable Solution	SCD	d0e11e4c-41c3-4874-b567-579db655fba3	3
311936	neostigmine methylsulfate 1 MG/ML Injectable Solution	SCD	d0e11e4c-41c3-4874-b567-579db655fba3	3
311935	neostigmine methylsulfate 0.5 MG/ML Injectable Solution	SY	d0e11e4c-41c3-4874-b567-579db655fba3	3
311936	neostigmine methylsulfate 1 MG/ML Injectable Solution	SY	d0e11e4c-41c3-4874-b567-579db655fba3	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-413-01	63323041301	10 mL in 1 VIAL, MULTI-DOSE	10 ml					Historical
63323-413-10	63323041310	10 VIAL, MULTI-DOSE in 1 TRAY (63323-413-10) / 10 mL in 1 VIAL, MULTI-DOSE (63323-413-01)		2015-01-08	0000-00-00	No	No	Current
63323-413-36	63323041336	10 VIAL, MULTI-DOSE in 1 TRAY (63323-413-36) / 10 mL in 1 VIAL, MULTI-DOSE		2015-01-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	2024-10-15	HUMAN PRESCRIPTION DRUG LABEL	3
Neostigmine Methylsulfate	Fresenius Kabi USA, LLC	2022-12-13	HUMAN PRESCRIPTION DRUG LABEL	4