GLYRX-PF
- Product NDC
- 51754-6000
- 11-digit product format
- 517546000
- Labeler code
- 51754
- Product ID
- 51754-6000_442634f7-9858-421d-91db-5bfdb21dcf13
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- glycopyrrolate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Exela Pharma Sciences, LLC
- Application
- NDA210997
- Marketing category
- NDA
- Marketing start
- 2018-08-01
- 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
- GLYRX-PF
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GLYCOPYRROLATE | .2 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | V92SO9WP2I |
| Rxcui | 1731582, 1731590, 2371710, 2371715, 2371718, 2371796, 2473383, 2473384 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51754-6000-4 | GLYRX-PF | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | 5 | |
| 51754-6000-4 | GLYRX-PF | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51754-6000-4 | ML - Milliliter | 51754-6000 | 81c1fe9e-e766-4a3d-8980-e60226b36057 | 1 | 2018-09-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51754-6000 | GLYRX-PF (GLYCOPYRROLATE) INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20230127_2189f3f5-39dc-4e85-b7c6-9515ded59686.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1731582 | glycopyrrolate 0.2 MG in 1 ML Injection | PSN | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 1731590 | glycopyrrolate 0.4 MG in 2 ML Injection | PSN | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2473383 | glycopyrrolate 0.6 MG in 3 mL Prefilled Syringe | PSN | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2371710 | glycopyrrolate 1 MG in 5 ML Prefilled Syringe | PSN | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2371718 | Glyrx-PF 0.2 MG in 1 ML Injection | PSN | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2371796 | Glyrx-PF 0.4 MG in 2 mL Injection | PSN | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2473384 | Glyrx-PF 0.6 MG in 3 mL Prefilled Syringe | PSN | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2371715 | Glyrx-PF 1 MG in 5 ML Prefilled Syringe | PSN | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2371718 | 1 ML glycopyrrolate 0.2 MG/ML Injection [Glyrx] | SBD | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2371796 | 2 ML glycopyrrolate 0.2 MG/ML Injection [Glyrx] | SBD | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2473384 | 3 ML glycopyrrolate 0.2 MG/ML Prefilled Syringe [Glyrx] | SBD | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2371715 | 5 ML glycopyrrolate 0.2 MG/ML Prefilled Syringe [Glyrx] | SBD | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 1731582 | 1 ML glycopyrrolate 0.2 MG/ML Injection | SCD | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 1731590 | 2 ML glycopyrrolate 0.2 MG/ML Injection | SCD | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2473383 | 3 ML glycopyrrolate 0.2 MG/ML Prefilled Syringe | SCD | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2371710 | 5 ML glycopyrrolate 0.2 MG/ML Prefilled Syringe | SCD | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2371718 | 1 ML Glyrx 0.2 MG/ML Injection | SY | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2371796 | 2 ML Glyrx 0.2 MG/ML Injection | SY | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2473384 | 3 ML Glyrx 0.2 MG/ML Prefilled Syringe | SY | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2371715 | 5 ML Glyrx 0.2 MG/ML Prefilled Syringe | SY | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 1731582 | glycopyrrolate 0.2 MG per 1 ML Injection | SY | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 1731590 | glycopyrrolate 0.4 MG per 2 ML Injection | SY | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2473383 | glycopyrrolate 0.6 MG per 3 ML Prefilled Syringe | SY | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2371710 | glycopyrrolate 1 MG per 5 ML Prefilled Syringe | SY | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2371718 | Glyrx-PF 0.2 MG per 1 ML Injection | SY | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2371796 | Glyrx-PF 0.4 MG per 2 ML Injection | SY | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2473384 | Glyrx-PF 0.6 MG per 3 ML Prefilled Syringe | SY | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
| 2371715 | Glyrx-PF 1 MG per 5 ML Prefilled Syringe | SY | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51754-6000-4 | 51754600004 | 25 VIAL, SINGLE-DOSE in 1 CARTON (51754-6000-4) / 1 mL in 1 VIAL, SINGLE-DOSE | 2018-08-01 | 0000-00-00 | No | No | Current |