NEOSTIGMINE METHYLSULFATE
- Product NDC
- 75834-149
- 11-digit product format
- 758340149
- Labeler code
- 75834
- Product ID
- 75834-149_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#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 75834-149 | | I | Inactivated by FDA | | 2026-07-31 |
| excluded package | package | 75834-149 | 75834-149-10 | I | Inactivated by FDA | | 2026-07-31 |
Orange Book products#
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#
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75834-149-01 | NEOSTIGMINE METHYLSULFATE | 01 in 1 CARTON | INJECTION | 01 | | 2 |
| 75834-149-01 | NEOSTIGMINE METHYLSULFATE | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION | 10 | | 2 |
| 75834-149-10 | 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 |
|---|
| 75834-149 | NEOSTIGMINE METHYLSULFATE INJECTION [NIVAGEN PHARMACEUTICALS, INC.] | 2 | Legacy NDC, 3 package rows | 20221121_dd6ddfa4-eee7-4027-b96e-c8b7ff04c55f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 75834-149-01 | 75834014901 | 01 in 1 CARTON | | | | | | Historical |
| 75834-149-10 | 75834014910 | 10 CARTON in 1 PACKAGE (75834-149-10) > 1 VIAL, MULTI-DOSE in 1 CARTON (75834-149-01) > 10 mL in 1 VIAL, MULTI-DOSE | 10 carton | 2022-11-21 | 0000-00-00 | No | No | Current |