Glycopyrrolate
- Product NDC
- 68083-378
- 11-digit product format
- 680830378
- Labeler code
- 68083
- Product ID
- 68083-378_92de5a0f-2918-4f66-a087-535c2dd0b3bd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA212612
- Marketing category
- ANDA
- Marketing start
- 2019-10-09
- 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
- 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 | .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 |
|---|
| 68083-378-01 | Glycopyrrolate | 5 mL in 1 VIAL | INJECTION | 5 | | 6 |
| 68083-378-25 | Glycopyrrolate | 25 in 1 CARTON | INJECTION | 25 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-378 | GLYCOPYRROLATE INJECTION [GLAND PHARMA LIMITED] | 4 | Current NDC, Legacy NDC, 2 package rows | 20221012_d670bd26-8a44-44be-90e1-107d4c380233.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 |
|---|
| 68083-378-01 | 68083037801 | 5 mL in 1 VIAL | 5 ml | | | | | Historical |
| 68083-378-25 | 68083037825 | 25 VIAL in 1 CARTON (68083-378-25) / 5 mL in 1 VIAL (68083-378-01) | 25 vial | 2019-10-09 | 0000-00-00 | No | No | Current |