Neostigmine methylsulfate
- Product NDC
- 68083-384
- 11-digit product format
- 680830384
- Labeler code
- 68083
- Product ID
- 68083-384_248b2834-6520-42e5-85cd-92c29eb7b804
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Neostigmine methylsulfate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA212968
- Marketing category
- ANDA
- Marketing start
- 2019-10-21
- Substance
- NEOSTIGMINE METHYLSULFATE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Neostigmine methylsulfate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NEOSTIGMINE METHYLSULFATE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 98IMH7M386 |
| Rxcui | 311935, 311936 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-384-01 | Neostigmine methylsulfate | 1 in 1 CARTON | INJECTION | 1 | | 5 |
| 68083-384-01 | Neostigmine methylsulfate | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION | 10 | | 5 |
| 68083-384-10 | Neostigmine methylsulfate | 10 in 1 CARTON | INJECTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-384 | NEOSTIGMINE METHYLSULFATE INJECTION [GLAND PHARMA LIMITED] | 4 | Current NDC, Legacy NDC, 3 package rows | 20210220_4eab6184-1771-4c15-a127-4eb3e47affc2.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 |
|---|
| 68083-384-01 | 68083038401 | 1 in 1 CARTON | | | | | | Historical |
| 68083-384-10 | 68083038410 | 10 CARTON in 1 CARTON (68083-384-10) / 1 VIAL, MULTI-DOSE in 1 CARTON (68083-384-01) / 10 mL in 1 VIAL, MULTI-DOSE | 10 carton | 2019-10-21 | 0000-00-00 | No | No | Current |