Pyridostigmine Bromide
- Product NDC
- 0115-1404
- 11-digit product format
- 001151404
- Labeler code
- 0115
- Product ID
- 0115-1404_cb2d3ee1-aeda-4c2c-85d2-3ff7d2de5689
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PYRIDOSTIGMINE BROMIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA203184
- Marketing category
- ANDA
- Marketing start
- 2015-09-18
- Marketing end
- 0000-00-00
- Substance
- PYRIDOSTIGMINE BROMIDE
- Active strength
- 180 mg/1
- Pharmacologic classes
- Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0115-1404-08 | Pyridostigmine Bromide | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PYRIDOSTIGMINE BROMIDE | ACTIVE INGREDIENT | KVI301NA53 | PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [IMPAX GENERICS] | 7 | |
| PYRIDOSTIGMINE | ACTIVE MOIETY | 19QM69HH21 | PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [IMPAX GENERICS] | 7 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [IMPAX GENERICS] | 7 | |
| COPOVIDONE K25-31 | INACTIVE INGREDIENT | D9C330MD8B | PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [IMPAX GENERICS] | 7 | |
| LACTOSE, UNSPECIFIED FORM | INACTIVE INGREDIENT | J2B2A4N98G | PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [IMPAX GENERICS] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [IMPAX GENERICS] | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [IMPAX GENERICS] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-1404 | PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 13 | Legacy NDC, 1 package rows | 20201230_013a6524-6eb9-4dbf-b29c-9aec2f40d2d0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0115-1404-08 | 00115140408 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0115-1404-08) | 2015-09-18 | 0000-00-00 | No | No | Current |