Nitroglycerin Transdermal System
- Product NDC
- 68382-309
- 11-digit product format
- 683820309
- Labeler code
- 68382
- Product ID
- 68382-309_1445184a-35fb-4ba3-bdb4-38a8c4fd1455
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitroglycerin Transdermal System
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA089884
- Marketing category
- ANDA
- Marketing start
- 2017-02-15
- Marketing end
- 0000-00-00
- Substance
- NITROGLYCERIN
- Active strength
- 0 mg/h
- Pharmacologic classes
- Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7480e90b-004b-ebe4-2243-4f2fefdd9e78 | Product name | 2 | 20260128 |
| 3f158398-73f2-4b90-47d1-5c60e8719a98 | Product name | 9 | 20250721 |
| ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0 | Product name | 2 | 20250117 |
| 00358076-c817-430b-b924-11d717dc307c | Product name | 1 | 20160718 |
| 669af5aa-14f3-3df7-f100-5f580ffd43c1 | Product name | 1 | 20140508 |
| 6ff3bab7-2dce-8bea-d7ce-54687f0c01fb | Product name | 1 | 20140508 |
| 8bb82a1c-d0d0-fc27-011f-172e545f0382 | Product name | 1 | 20140508 |
| cb03406d-e223-80bb-67d8-be80f9b6a4f2 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68382-309-30 | 2024-01-30 | C162847 | 48780-1 | 1030e365-569c-111a-e063-dadaa90a10e2 | Nitroglycerin Transdermal System Rx only Prescribing Information |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68382-309-01 | Nitroglycerin Transdermal System | 14 h in 1 PATCH | PATCH, EXTENDED RELEASE | 14 | 5 | |
| 68382-309-01 | Nitroglycerin Transdermal System | 1 in 1 POUCH | PATCH, EXTENDED RELEASE | 1 | 5 | |
| 68382-309-30 | Nitroglycerin Transdermal System | 30 in 1 CARTON | PATCH, EXTENDED RELEASE | 30 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68382-309-01 | EA - Each | 68382-309 | 36d7eb92-6fc8-4635-9f68-1d9deb73e940 | 1 | 2017-03-06 |
| 68382-309-30 | EA - Each | 68382-309 | 5c98c65f-f7a0-49c1-9d61-f1696441359b | 1 | 2017-03-06 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 486148 | nitroglycerin 0.2 MG/HR 24HR Transdermal System | PSN | e3da9f52-d094-49d2-90d8-994bd839a4a7 | 5 |
| 486152 | nitroglycerin 0.4 MG/HR 24HR Transdermal System | PSN | e3da9f52-d094-49d2-90d8-994bd839a4a7 | 5 |
| 486146 | nitroglycerin 0.6 MG/HR 24HR Transdermal System | PSN | e3da9f52-d094-49d2-90d8-994bd839a4a7 | 5 |
| 486148 | 24 HR nitroglycerin 0.2 MG/HR Transdermal System | SCD | e3da9f52-d094-49d2-90d8-994bd839a4a7 | 5 |
| 486152 | 24 HR nitroglycerin 0.4 MG/HR Transdermal System | SCD | e3da9f52-d094-49d2-90d8-994bd839a4a7 | 5 |
| 486146 | 24 HR nitroglycerin 0.6 MG/HR Transdermal System | SCD | e3da9f52-d094-49d2-90d8-994bd839a4a7 | 5 |
| 486148 | 24 HR NTG 0.2 MG/HR Transdermal System | SY | e3da9f52-d094-49d2-90d8-994bd839a4a7 | 5 |
| 486152 | 24 HR NTG 0.4 MG/HR Transdermal System | SY | e3da9f52-d094-49d2-90d8-994bd839a4a7 | 5 |
| 486146 | 24 HR NTG 0.6 MG/HR Transdermal System | SY | e3da9f52-d094-49d2-90d8-994bd839a4a7 | 5 |
| 486148 | 24 HR TNG 0.2 MG/HR Transdermal System | SY | e3da9f52-d094-49d2-90d8-994bd839a4a7 | 5 |
| 486152 | 24 HR TNG 0.4 MG/HR Transdermal System | SY | e3da9f52-d094-49d2-90d8-994bd839a4a7 | 5 |
| 486146 | 24 HR TNG 0.6 MG/HR Transdermal System | SY | e3da9f52-d094-49d2-90d8-994bd839a4a7 | 5 |
| 486148 | nitroglycerin 0.2 MG/HR 24HR Transdermal System | SY | e3da9f52-d094-49d2-90d8-994bd839a4a7 | 5 |
| 486152 | nitroglycerin 0.4 MG/HR 24HR Transdermal System | SY | e3da9f52-d094-49d2-90d8-994bd839a4a7 | 5 |
| 486146 | nitroglycerin 0.6 MG/HR 24HR Transdermal System | SY | e3da9f52-d094-49d2-90d8-994bd839a4a7 | 5 |
| 486152 | nitroglycerin 10 MG/Day 24 HR Transdermal Patch | SY | e3da9f52-d094-49d2-90d8-994bd839a4a7 | 5 |
| 486146 | nitroglycerin 14 MG/Day 24 HR Transdermal Patch | SY | e3da9f52-d094-49d2-90d8-994bd839a4a7 | 5 |
| 486148 | nitroglycerin 5 MG/Day 24 HR Transdermal Patch | SY | e3da9f52-d094-49d2-90d8-994bd839a4a7 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68382-309-01 | 68382030901 | 14 h in 1 PATCH | 14 h | Historical | ||||
| 68382-309-30 | 68382030930 | 30 POUCH in 1 CARTON (68382-309-30) > 1 PATCH in 1 POUCH (68382-309-01) > 14 h in 1 PATCH | 30 pouch | 2017-02-15 | 0000-00-00 | No | No | Current |