GLYCOPYRROLATE
- Product NDC
- 51662-1601
- 11-digit product format
- 516621601
- Labeler code
- 51662
- Product ID
- 51662-1601_0f926dfb-69bc-4d9f-e063-6394a90a1e71
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GLYCOPYRROLATE
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA090963
- Marketing category
- ANDA
- Marketing start
- 2022-08-29
- 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
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1601-1 | GLYCOPYRROLATE | 5 mL in 1 VIAL | INJECTION | 5 | | 4 |
| 51662-1601-2 | GLYCOPYRROLATE | 1 in 1 POUCH | INJECTION | 1 | | 4 |
| 51662-1601-2 | GLYCOPYRROLATE | 5 mL in 1 VIAL | INJECTION | 5 | | 4 |
| 51662-1601-3 | GLYCOPYRROLATE | 25 in 1 CASE | INJECTION | 25 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1601 | GLYCOPYRROLATE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240123_e76bc0e4-68f5-70b4-e053-2a95a90a451e.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 |
|---|
| 51662-1601-1 | 51662160101 | 5 mL in 1 VIAL (51662-1601-1) | 5 ml | 2022-08-29 | 0000-00-00 | No | No | Current |
| 51662-1601-2 | 51662160102 | 1 in 1 POUCH | | | | | | Historical |
| 51662-1601-3 | 51662160103 | 25 POUCH in 1 CASE (51662-1601-3) / 1 VIAL in 1 POUCH (51662-1601-2) / 5 mL in 1 VIAL | 25 pouch | 2023-01-19 | | No | No | Historical |