GLYCOPYRROLATE
- Product NDC
- 75834-195
- 11-digit product format
- 758340195
- Labeler code
- 75834
- Product ID
- 75834-195_29803114-1d00-4e06-9a14-b75895c85f5a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- glycopyrrolate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Nivagen Pharmaceuticals, Inc.
- Application
- ANDA212591
- Marketing category
- ANDA
- Marketing start
- 2021-10-25
- 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 | 238212, 1731582, 1731590 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75834-195-25 | GLYCOPYRROLATE | 25 in 1 CARTON | INJECTION | 25 | | 3 |
| 75834-195-25 | GLYCOPYRROLATE | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75834-195 | GLYCOPYRROLATE INJECTION [NIVAGEN PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20211030_7cb1ecbe-1e7a-4b39-8e1d-0c20f145e177.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 75834-195-25 | 75834019525 | 25 VIAL, MULTI-DOSE in 1 CARTON (75834-195-25) / 5 mL in 1 VIAL, MULTI-DOSE | 2021-10-25 | 0000-00-00 | No | No | Current |