Glycopyrrolate
- Product NDC
- 76045-223
- 11-digit product format
- 760450223
- Labeler code
- 76045
- Product ID
- 76045-223_1925138e-94b7-4e29-815e-f6681943a734
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA214919
- Marketing category
- NDA
- Marketing start
- 2022-04-21
- 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 | 2473383 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76045-223-03 | Glycopyrrolate | 3 mL in 1 SYRINGE | INJECTION | 3 | | 7 |
| 76045-223-30 | Glycopyrrolate | 10 in 1 CARTON | INJECTION | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76045-223 | GLYCOPYRROLATE (GLYCOPYRROLATE) INJECTION [FRESENIUS KABI USA, LLC] | 7 | Current NDC, 2 package rows | 20240606_685aaf64-1a64-42f9-a96f-4764d650c26f.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 |
|---|
| 76045-223-03 | 76045022303 | 3 mL in 1 SYRINGE | 3 ml | | | | Historical |
| 76045-223-30 | 76045022330 | 10 SYRINGE in 1 CARTON (76045-223-30) / 3 mL in 1 SYRINGE (76045-223-03) | 10 syringe | 2022-04-21 | No | No | Historical |