Salagen
- Product NDC
- 59212-775
- 11-digit product format
- 592120775
- Labeler code
- 59212
- Product ID
- 59212-775_5e2a19b9-0694-43ac-9e0e-b40048495a1b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pilocarpine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanz Pharma (US) Corp.
- Application
- NDA020237
- Marketing category
- NDA
- Marketing start
- 2019-09-01
- Substance
- PILOCARPINE HYDROCHLORIDE
- Active strength
- 7.5 mg/1
- Pharmacologic classes
- Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Salagen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PILOCARPINE HYDROCHLORIDE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0WW6D218XJ |
| Rxcui | 1000913, 1000915, 1001004, 1001006 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59212-775-10 | Salagen | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59212-775 | SALAGEN (PILOCARPINE HYDROCHLORIDE) TABLET, FILM COATED [ADVANZ PHARMA (US) CORP.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241220_62eda83d-d043-4c7e-8fcf-75d05efbf35b.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 |
|---|
| 59212-775-10 | 59212077510 | 100 TABLET, FILM COATED in 1 BOTTLE (59212-775-10) | 2019-09-01 | 0000-00-00 | No | No | Current |