GLYCOPYRROLATE
- Product NDC
- 0404-9867
- 11-digit product format
- 004049867
- Labeler code
- 0404
- Product ID
- 0404-9867_61f3818f-a99e-4169-9e8f-20a9f4bf1853
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GLYCOPYRROLATE
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA090963
- Marketing category
- ANDA
- Marketing start
- 2022-01-10
- Marketing end
- 2026-08-31
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GLYCOPYRROLATE
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYCOPYRROLATE | .2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V92SO9WP2I |
| Rxcui | 1731582 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9867-01 | GLYCOPYRROLATE | 1 mL in 1 VIAL | INJECTION | 1 | | 7 |
| 0404-9867-01 | GLYCOPYRROLATE | 1 in 1 BAG | INJECTION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9867 | GLYCOPYRROLATE INJECTION [HENRY SCHEIN, INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250201_225d95b4-7f8f-44c2-8fc2-93b75d9cc651.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 |
|---|
| 0404-9867-01 | 00404986701 | 1 VIAL in 1 BAG (0404-9867-01) / 1 mL in 1 VIAL | 1 vial | 2022-01-10 | 2026-08-31 | No | No | Current |