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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N210997-001 | GLYRX-PF | GLYCOPYRROLATE | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2018-07-11 | |
| N210997-002 | GLYRX-PF | GLYCOPYRROLATE | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | |
| N210997-003 | GLYRX-PF | GLYCOPYRROLATE | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | |
| N210997-004 | GLYRX-PF | GLYCOPYRROLATE | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2018-07-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-12-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N210997-001 | GLYRX-PF | 0.2MG/ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N210997-002 | GLYRX-PF | 0.4MG/2ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2018-07-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N210997-003 | GLYRX-PF | 1MG/5ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD, RS | 2020-04-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N210997-004 | GLYRX-PF | 0.6MG/3ML (0.2MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS | RLD | 2020-12-14 | d06236e962d9… |
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 UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V92SO9WP2I | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1731582 | Internal RxNorm lookup |
| 1731590 | Internal RxNorm lookup |
| 2371710 | Internal RxNorm lookup |
| 2371715 | Internal RxNorm lookup |
| 2371718 | Internal RxNorm lookup |
| 2371796 | Internal RxNorm lookup |
| 2473383 | Internal RxNorm lookup |
| 2473384 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2189f3f5-39dc-4e85-b7c6-9515ded59686 | Available on FDA.report |
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 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| GLYRX-PF | GLYCOPYRROLATE | Exela Pharma Sciences, LLC | 2189f3f5-39dc-4e85-b7c6-9515ded59686 | 2025-07-23 | Warnings, Adverse reactions | 210997 NDA210997 51754-6000 |
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 |