Glycopyrrolate
- Product NDC
- 65219-801
- 11-digit product format
- 652190801
- Labeler code
- 65219
- Product ID
- 65219-801_516b2ac1-7eab-4d63-a0d0-97245858a1d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA209328
- Marketing category
- ANDA
- Marketing start
- 2023-12-31
- Substance
- GLYCOPYRROLATE
- Active strength
- .2 mg/mL
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Glycopyrrolate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYCOPYRROLATE | .2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V92SO9WP2I |
| Rxcui | 1731582 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-801-00 | Glycopyrrolate | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 4 |
| 65219-801-01 | Glycopyrrolate | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-801 | GLYCOPYRROLATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | Current NDC, 2 package rows | 20231231_250eeef7-b1a9-45e7-a927-7807232e10be.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65219-801-00 | 65219080100 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | Historical |
| 65219-801-01 | 65219080101 | 25 VIAL, SINGLE-DOSE in 1 CARTON (65219-801-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-801-00) | | 2023-12-31 | No | No | Historical |