Neostigmine Methylsulfate

Product NDC
23155-518
11-digit product format
231550518
Labeler code
23155
Product ID
23155-518_fe40568f-ed8b-43fe-987f-839427a5924f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neostigmine Methylsulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA208230
Marketing category
ANDA
Marketing start
2022-11-25
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208230-001NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-11-25
A208230-002NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2022-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208230-001AP
A208230-002AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-11-08 22:44 UTC · 2 captures of this ZIP2024-11A208230-001NEOSTIGMINE METHYSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 2 captures of this ZIP2024-11A208230-002NEOSTIGMINE METHYSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2022-11-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208230-001NEOSTIGMINE METHYSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A208230-002NEOSTIGMINE METHYSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2022-11-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208230-001NEOSTIGMINE METHYSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-11-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208230-002NEOSTIGMINE METHYSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2022-11-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208230-001NEOSTIGMINE METHYSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-11-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208230-002NEOSTIGMINE METHYSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2022-11-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208230-001NEOSTIGMINE METHYSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-11-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208230-002NEOSTIGMINE METHYSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2022-11-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208230-001NEOSTIGMINE METHYSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-11-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208230-002NEOSTIGMINE METHYSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2022-11-258072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208230-001NEOSTIGMINE METHYSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-11-256a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208230-002NEOSTIGMINE METHYSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2022-11-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208230-001NEOSTIGMINE METHYSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-11-251c564ffb4f44…
2024-02-18 07:12 UTC2024-02A208230-002NEOSTIGMINE METHYSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2022-11-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208230-001NEOSTIGMINE METHYSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-11-25ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A208230-002NEOSTIGMINE METHYSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2022-11-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208230-001NEOSTIGMINE METHYSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-11-25a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208230-002NEOSTIGMINE METHYSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2022-11-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208230-001NEOSTIGMINE METHYSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-11-259b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208230-002NEOSTIGMINE METHYSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2022-11-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208230-001NEOSTIGMINE METHYSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-11-25a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208230-002NEOSTIGMINE METHYSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2022-11-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208230-001NEOSTIGMINE METHYSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-11-253f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208230-002NEOSTIGMINE METHYSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2022-11-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A208230-001NEOSTIGMINE METHYSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-11-25053a50430f4f…
2023-05-13 08:27 UTC2023-05A208230-002NEOSTIGMINE METHYSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2022-11-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A208230-001NEOSTIGMINE METHYSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-11-253bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A208230-002NEOSTIGMINE METHYSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2022-11-253bdfa0b2c4d7…
2026-08-01 22:54:322026-06A208230-001NEOSTIGMINE METHYLSULFATE5MG/10ML (0.5MG/ML)SOLUTION / INTRAVENOUSAP2022-11-25a50c72e98297…
2026-08-01 22:54:322026-06A208230-002NEOSTIGMINE METHYLSULFATE10MG/10ML (1MG/ML)SOLUTION / INTRAVENOUSAP2022-11-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-11-08 22:44 UTC · 2 captures of this ZIP2024-11A208230-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 2 captures of this ZIP2024-11A208230-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208230-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208230-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208230-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208230-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208230-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208230-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208230-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208230-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208230-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208230-002AP18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208230-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208230-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208230-001AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A208230-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208230-001AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A208230-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208230-001AP1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208230-002AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208230-001AP19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208230-002AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208230-001AP1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208230-002AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208230-001AP13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208230-002AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208230-001AP1053a50430f4f…
2023-05-13 08:27 UTC2023-05A208230-002AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208230-001AP13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A208230-002AP13bdfa0b2c4d7…
2026-08-01 22:54:322026-06A208230-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A208230-002AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neostigmine MethylsulfateNEOSTIGMINE METHYLSULFATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.9cc2bfa1-c968-4d01-8162-2ef1889741642026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208230
application number: ANDA208230
ndc (product): 23155-518

Additional Listing Data#

Finished product
Yes
Brand name base
Neostigmine Methylsulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOSTIGMINE METHYLSULFATE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98IMH7M386Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311935Internal RxNorm lookup
311936Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9cc2bfa1-c968-4d01-8162-2ef188974164Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f58f10d3-5fa9-4c2e-9a6e-77029e9ed80bProduct name120231002
6c2b16d0-96e9-444e-98c5-9883cd6eb72dProduct name220230316
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
ad279e69-d021-f6bd-1150-2b55f23832d5Product name920211014
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-518-31Neostigmine Methylsulfate10 mL in 1 VIALINJECTION108
23155-518-41Neostigmine Methylsulfate10 in 1 CARTONINJECTION108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-518-31ML - Milliliter23155-518178c7eb8-09e1-4c28-b31b-6633942e5e8512024-07-12
23155-518-41ML - Milliliter23155-51822145c8a-3a64-41f5-b59b-406c3604324812024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-518NEOSTIGMINE METHYLSULFATE INJECTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 2 package rows20240620_9cc2bfa1-c968-4d01-8162-2ef188974164.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionPSN9cc2bfa1-c968-4d01-8162-2ef1889741648
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionPSN9cc2bfa1-c968-4d01-8162-2ef1889741648
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSCD9cc2bfa1-c968-4d01-8162-2ef1889741648
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSCD9cc2bfa1-c968-4d01-8162-2ef1889741648
311935neostigmine methylsulfate 0.5 MG/ML Injectable SolutionSY9cc2bfa1-c968-4d01-8162-2ef1889741648
311936neostigmine methylsulfate 1 MG/ML Injectable SolutionSY9cc2bfa1-c968-4d01-8162-2ef1889741648

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-518-312315505183110 mL in 1 VIAL10 mlHistorical
23155-518-412315505184110 VIAL in 1 CARTON (23155-518-41) / 10 mL in 1 VIAL (23155-518-31) 10 vial2022-11-250000-00-00NoNoCurrent