Glycopyrrolate
- Product NDC
- 0517-4620
- 11-digit product format
- 005174620
- Labeler code
- 0517
- Product ID
- 0517-4620_ad03d273-8f44-48f2-bc0e-4dd8dbf08507
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- American Regent, Inc.
- Application
- ANDA089335
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- Substance
- GLYCOPYRROLATE
- Active strength
- .2 mg/mL
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic 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 | 238212, 1731582, 1731590 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0517-4620-25 | Glycopyrrolate | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 20 | | 11 |
| 0517-4620-25 | Glycopyrrolate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0517-4620 | GLYCOPYRROLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240208_62267afe-1a73-4623-984e-646db590ec5b.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 |
|---|
| 0517-4620-25 | 00517462025 | 25 VIAL, MULTI-DOSE in 1 TRAY (0517-4620-25) / 20 mL in 1 VIAL, MULTI-DOSE | 1990-09-30 | 0000-00-00 | No | No | Current |