FDA.reportPublic FDA data

ANTICHOLIUM

Product NDC
81284-831
11-digit product format
812840831
Labeler code
81284
Product ID
81284-831_7c1db393-3664-425f-af20-8d2175fb634e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
physostigmine salicylate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Provepharm Inc.
Marketing category
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start
2023-10-05
Substance
PHYSOSTIGMINE SALICYLATE
Active strength
.4 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ANTICHOLIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHYSOSTIGMINE SALICYLATE.4 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2046ZRO9VUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2666367Internal RxNorm lookup
2666374Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b90b50e8-c8f1-4f2d-be6e-4d269b8c362cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81284-831-05ANTICHOLIUM5 mL in 1 AMPULEINJECTION53
81284-831-05ANTICHOLIUM5 in 1 CARTONINJECTION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81284-831-05ML - Milliliter81284-83160948263-97d8-4371-85f3-3e089417ad7312024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81284-831ANTICHOLIUM (PHYSOSTIGMINE SALICYLATE) INJECTION [PROVEPHARM INC.]2Current NDC, 2 package rows20241109_b90b50e8-c8f1-4f2d-be6e-4d269b8c362c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTICHOLIUMPHYSOSTIGMINE SALICYLATEProvepharm Inc.b90b50e8-c8f1-4f2d-be6e-4d269b8c362c2025-11-11Warnings, Adverse reactionsExact identifier
ndc (product): 81284-831

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2666374ANTICHOLIUM 2 MG in 5 ML InjectionPSNb90b50e8-c8f1-4f2d-be6e-4d269b8c362c3
2666367PHYSostigmine salicylate 2 MG in 5 ML InjectionPSNb90b50e8-c8f1-4f2d-be6e-4d269b8c362c3
26663745 ML physostigmine salicylate 0.4 MG/ML Injection [Anticholium]SBDb90b50e8-c8f1-4f2d-be6e-4d269b8c362c3
26663675 ML physostigmine salicylate 0.4 MG/ML InjectionSCDb90b50e8-c8f1-4f2d-be6e-4d269b8c362c3
26663745 ML Anticholium 0.4 MG/ML InjectionSYb90b50e8-c8f1-4f2d-be6e-4d269b8c362c3
2666374Anticholium 2 MG per 5 ML InjectionSYb90b50e8-c8f1-4f2d-be6e-4d269b8c362c3
2666367physostigmine salicylate 2 MG per 5 ML InjectionSYb90b50e8-c8f1-4f2d-be6e-4d269b8c362c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81284-831-05812840831055 AMPULE in 1 CARTON (81284-831-05) / 5 mL in 1 AMPULE5 ampule2023-10-05NoNoCurrent