GLYCOPYRROLATE
- Product NDC
- 43547-640
- 11-digit product format
- 435470640
- Labeler code
- 43547
- Product ID
- 43547-640_8a403c54-3e23-41fc-bf80-c40e8d867aa2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- glycopyrrolate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Solco Healthcare US, LLC
- Application
- ANDA210927
- Marketing category
- ANDA
- Marketing start
- 2019-03-20
- Substance
- GLYCOPYRROLATE
- Active strength
- .4 mg/2mL
- 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 | .4 mg/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V92SO9WP2I |
| Rxcui | 1731582, 1731590 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43547-640-01 | GLYCOPYRROLATE | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 2 | | 3 |
| 43547-640-25 | GLYCOPYRROLATE | 25 in 1 CARTON | INJECTION | 25 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-640 | GLYCOPYRROLATE INJECTION [SOLCO HEALTHCARE US, LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20210903_2972f22e-378c-450b-8869-1354a9bd0ffc.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 |
|---|
| 43547-640-01 | 43547064001 | 2 mL in 1 VIAL, SINGLE-DOSE | 2 ml | | | | | Historical |
| 43547-640-25 | 43547064025 | 25 VIAL, SINGLE-DOSE in 1 CARTON (43547-640-25) / 2 mL in 1 VIAL, SINGLE-DOSE (43547-640-01) | | 2021-05-01 | 0000-00-00 | No | No | Current |