Regonol
- Product NDC
- 0781-3040
- 11-digit product format
- 007813040
- Labeler code
- 0781
- Product ID
- 0781-3040_eaf2bbb9-562b-0e4e-e053-2a95a90abdea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pyridostigmine Bromide
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; PARENTERAL
- Labeler
- Sandoz Inc
- Application
- NDA017398
- Marketing category
- NDA
- Marketing start
- 2005-05-10
- Substance
- PYRIDOSTIGMINE BROMIDE
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Regonol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PYRIDOSTIGMINE BROMIDE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KVI301NA53 |
| Rxcui | 903851, 903855 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0781-3040-72 | Regonol | 2 mL in 1 AMPULE | INJECTION, SOLUTION | 2 | | 20 |
| 0781-3040-95 | Regonol | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 20 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-3040 | REGONOL (PYRIDOSTIGMINE BROMIDE) INJECTION, SOLUTION [SANDOZ INC] | 20 | Current NDC, Legacy NDC, 2 package rows | 20221014_208af931-a44e-43bf-a265-8e08534dc55f.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 |
|---|
| 0781-3040-72 | 00781304072 | 2 mL in 1 AMPULE | 2 ml | | | | | Historical |
| 0781-3040-95 | 00781304095 | 10 AMPULE in 1 CARTON (0781-3040-95) / 2 mL in 1 AMPULE (0781-3040-72) | 10 ampule | 2005-05-10 | 0000-00-00 | No | No | Current |