Glycopyrrolate
- Product NDC
- 70069-012
- 11-digit product format
- 700690012
- Labeler code
- 70069
- Product ID
- 70069-012_1cf06d0b-356a-4f2a-af3c-bbcd7e24aae9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA211705
- Marketing category
- ANDA
- Marketing start
- 2022-01-29
- 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 |
|---|
| 70069-012-01 | Glycopyrrolate | 2 mL in 1 VIAL | INJECTION | 2 | | 12 |
| 70069-012-25 | Glycopyrrolate | 25 in 1 CARTON | INJECTION | 25 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-012 | GLYCOPYRROLATE INJECTION [SOMERSET THERAPEUTICS, LLC] | 12 | Current NDC, Legacy NDC, 2 package rows | 20220603_a46c5ec1-a1b4-46fc-9b37-8da7f0c983d6.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 |
|---|
| 70069-012-01 | 70069001201 | 2 mL in 1 VIAL | 2 ml | | | | | Historical |
| 70069-012-25 | 70069001225 | 25 VIAL in 1 CARTON (70069-012-25) / 2 mL in 1 VIAL (70069-012-01) | 25 vial | 2022-01-29 | 0000-00-00 | No | No | Current |