Glycopyrrolate
- Product NDC
- 70121-1395
- 11-digit product format
- 701211395
- Labeler code
- 70121
- Product ID
- 70121-1395_eef9f866-2de4-4bc2-881d-c0dcb5422d3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glycopyrrolate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA208973
- Marketing category
- ANDA
- Marketing start
- 2017-06-15
- Substance
- GLYCOPYRROLATE
- Active strength
- .4 mg/2mL
- 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 |
|---|---|
| GLYCOPYRROLATE | .4 mg/2mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | V92SO9WP2I |
| Rxcui | 238212, 1731582, 1731590 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 138c3de2-4b03-4255-92b5-f022482d81bc | Product name | 4 | 20260113 |
| 4dc252b1-bb5f-8bb6-4fa8-f3a45efd810e | Product name | 5 | 20250304 |
| f58f10d3-5fa9-4c2e-9a6e-77029e9ed80b | Product name | 1 | 20231002 |
| 76dcac30-469f-4f92-9c55-70950d209446 | Product name | 1 | 20230809 |
| 132196a6-5117-4b6e-a9dd-27f2793580c6 | Product name | 1 | 20230112 |
| ac1f888b-a1db-4d2e-abbc-973f21c2ce1b | Product name | 1 | 20220720 |
| d84dd569-7bf0-1410-25eb-017ef37dd406 | Product name | 9 | 20210902 |
| 7d8c8d5a-f174-4e6b-97b1-6fd615c5df9a | Product name | 1 | 20210204 |
| 58b12de9-b891-41c7-9be6-ff47de5ec28b | Product name | 1 | 20180828 |
| 9aff7b10-8e47-4b10-9a92-803440a37ce2 | Product name | 1 | 20180206 |
| ce066c73-ca6f-49fc-83d4-d3cf6728e8a1 | Product name | 1 | 20160616 |
| fb29b8a9-c2d0-42bb-aea8-9bc2a87db75a | Product name | 1 | 20151113 |
| ab7ba50c-5a47-47e6-8dd6-fa32a52559f6 | Product name | 1 | 20151109 |
| 29ae08d1-069f-9822-4820-152d5dc67797 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70121-1395-1 | Glycopyrrolate | 2 mL in 1 VIAL | INJECTION | 2 | 10 | |
| 70121-1395-5 | Glycopyrrolate | 25 in 1 CARTON | INJECTION | 25 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70121-1395-1 | ML - Milliliter | 70121-1395 | 5c393af5-ccb7-40df-8122-416808004a35 | 1 | 2017-07-07 |
| 70121-1395-5 | ML - Milliliter | 70121-1395 | f38efc78-0056-4d69-854f-c9c79356dd66 | 1 | 2017-07-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70121-1395 | GLYCOPYRROLATE INJECTION [AMNEAL PHARMACEUTICALS LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240730_bbab4cf1-0441-4fc4-9de9-e4117fa19faa.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1731582 | glycopyrrolate 0.2 MG in 1 ML Injection | PSN | bbab4cf1-0441-4fc4-9de9-e4117fa19faa | 10 |
| 238212 | glycopyrrolate 0.2 MG/ML Injectable Solution | PSN | bbab4cf1-0441-4fc4-9de9-e4117fa19faa | 10 |
| 1731590 | glycopyrrolate 0.4 MG in 2 ML Injection | PSN | bbab4cf1-0441-4fc4-9de9-e4117fa19faa | 10 |
| 1731582 | 1 ML glycopyrrolate 0.2 MG/ML Injection | SCD | bbab4cf1-0441-4fc4-9de9-e4117fa19faa | 10 |
| 1731590 | 2 ML glycopyrrolate 0.2 MG/ML Injection | SCD | bbab4cf1-0441-4fc4-9de9-e4117fa19faa | 10 |
| 238212 | glycopyrrolate 0.2 MG/ML Injectable Solution | SCD | bbab4cf1-0441-4fc4-9de9-e4117fa19faa | 10 |
| 1731582 | glycopyrrolate 0.2 MG per 1 ML Injection | SY | bbab4cf1-0441-4fc4-9de9-e4117fa19faa | 10 |
| 1731590 | glycopyrrolate 0.4 MG per 2 ML Injection | SY | bbab4cf1-0441-4fc4-9de9-e4117fa19faa | 10 |
| 1731590 | glycopyrrolate 0.4 MG in 2 ML Injection | PSN | 55c9c26b-d08f-488f-a07c-c0dbb794a667 | 4 |
| 1731590 | 2 ML glycopyrrolate 0.2 MG/ML Injection | SCD | 55c9c26b-d08f-488f-a07c-c0dbb794a667 | 4 |
| 1731590 | glycopyrrolate 0.4 MG per 2 ML Injection | SY | 55c9c26b-d08f-488f-a07c-c0dbb794a667 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70121-1395-1 | 70121139501 | 2 mL in 1 VIAL | 2 ml | Historical | ||||
| 70121-1395-5 | 70121139505 | 25 VIAL in 1 CARTON (70121-1395-5) / 2 mL in 1 VIAL (70121-1395-1) | 25 vial | 2017-06-15 | 0000-00-00 | No | No | Current |