Glycopyrrolate
- Product NDC
- 62135-961
- 11-digit product format
- 621350961
- Labeler code
- 62135
- Product ID
- 62135-961_32fec6b3-f126-b5b6-e063-6394a90ab77d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA216368
- Marketing category
- ANDA
- Marketing start
- 2024-08-28
- Substance
- GLYCOPYRROLATE
- Active strength
- 1 mg/5mL
- 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 | 1 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V92SO9WP2I |
| Rxcui | 999961 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-961-47 | Glycopyrrolate | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-961 | GLYCOPYRROLATE SOLUTION [CHARTWELL RX, LLC] | 1 | Current NDC, 1 package rows | 20250418_89090b34-470c-478c-be49-1d2bc48a28f8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-961-47 | 62135096147 | 473 mL in 1 BOTTLE (62135-961-47) | 473 ml | 2025-04-11 | No | No | Historical |