Glycopyrrolate
- Product NDC
- 0781-3829
- 11-digit product format
- 007813829
- Labeler code
- 0781
- Product ID
- 0781-3829_61974545-5e98-4c25-8ce4-6b9c7fd28d40
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Sandoz Inc
- Application
- ANDA211334
- Marketing category
- ANDA
- Marketing start
- 2019-07-22
- Substance
- GLYCOPYRROLATE
- Active strength
- 1 mg/5mL
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Glycopyrrolate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYCOPYRROLATE | 1 mg/5mL |
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 |
|---|
| 0781-3829-75 | Glycopyrrolate | 5 mL in 1 VIAL | INJECTION | 5 | | 11 |
| 0781-3829-96 | Glycopyrrolate | 25 in 1 CARTON | INJECTION | 25 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-3829 | GLYCOPYRROLATE INJECTION [SANDOZ INC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20221015_cb1ae370-ec4f-4114-9860-8f736f72b545.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 |
|---|
| 0781-3829-75 | 00781382975 | 5 mL in 1 VIAL | 5 ml | | | | | Historical |
| 0781-3829-96 | 00781382996 | 25 VIAL in 1 CARTON (0781-3829-96) / 5 mL in 1 VIAL (0781-3829-75) | 25 vial | 2019-07-22 | 0000-00-00 | No | No | Current |