Glycopyrrolate
- Product NDC
- 76045-203
- 11-digit product format
- 760450203
- Labeler code
- 76045
- Product ID
- 76045-203_d8f5e3e4-34e3-4e52-b76d-69e210e649d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA209024
- Marketing category
- ANDA
- Marketing start
- 2018-07-25
- 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 | 2101490, 2101495 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76045-203-01 | Glycopyrrolate | 1 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 1 | | 8 |
| 76045-203-01 | Glycopyrrolate | 1 in 1 BLISTER PACK | INJECTION, SOLUTION | 1 | | 8 |
| 76045-203-02 | Glycopyrrolate | 2 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 2 | | 8 |
| 76045-203-02 | Glycopyrrolate | 1 in 1 BLISTER PACK | INJECTION, SOLUTION | 1 | | 8 |
| 76045-203-10 | Glycopyrrolate | 24 in 1 CARTON | INJECTION, SOLUTION | 24 | | 8 |
| 76045-203-20 | Glycopyrrolate | 24 in 1 CARTON | INJECTION, SOLUTION | 24 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76045-203 | GLYCOPYRROLATE (GLYCOPYRROLATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] | 8 | Current NDC, Legacy NDC, 6 package rows | 20230825_88d3e865-8dca-4c89-b6f7-a34c481f75b9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76045-203-01 | 76045020301 | 1 mL in 1 SYRINGE, GLASS | 1 ml | | | | | Historical |
| 76045-203-02 | 76045020302 | 2 mL in 1 SYRINGE, GLASS | 2 ml | | | | | Historical |
| 76045-203-10 | 76045020310 | 24 BLISTER PACK in 1 CARTON (76045-203-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-203-01) / 1 mL in 1 SYRINGE, GLASS | 24 blister pack | 2018-07-25 | 0000-00-00 | No | No | Current |
| 76045-203-20 | 76045020320 | 24 BLISTER PACK in 1 CARTON (76045-203-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-203-02) / 2 mL in 1 SYRINGE, GLASS | 24 blister pack | 2018-07-25 | 0000-00-00 | No | No | Current |