NITRO-BID
- Product NDC
- 0281-0326
- 11-digit product format
- 002810326
- Labeler code
- 0281
- Product ID
- 0281-0326_0011b0f7-715e-4daf-9e6b-a787a83e18f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitroglycerin
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Savage Laboratories a division of Fougera Pharmaceuticals, LLC
- Application
- ANDA087355
- Marketing category
- ANDA
- Marketing start
- 2009-08-15
- Substance
- NITROGLYCERIN
- Active strength
- 20 mg/g
- Pharmacologic classes
- Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NITRO-BID
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NITROGLYCERIN | 20 mg/g |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | G59M7S0WS3 |
| Rxcui | 207273, 242946 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0281-0326-08 | NITRO-BID | 48 in 1 BOX | OINTMENT | 48 | 15 | |
| 0281-0326-08 | NITRO-BID | 1 g in 1 PACKET | OINTMENT | 1 | 15 | |
| 0281-0326-30 | NITRO-BID | 30 g in 1 TUBE | OINTMENT | 30 | 15 | |
| 0281-0326-60 | NITRO-BID | 60 g in 1 TUBE | OINTMENT | 60 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0281-0326-08 | GM - Gram | 0281-0326 | af77d083-dc82-4c87-ac9a-49eda2aa5906 | 1 | 2012-07-24 |
| 0281-0326-30 | GM - Gram | 0281-0326 | bd40409e-e9ee-44a0-bbfd-40079697f24b | 1 | 2012-07-24 |
| 0281-0326-60 | GM - Gram | 0281-0326 | 9b3daa75-4d2e-40fe-a922-c84571365496 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| nitroglycerin | ACTIVE INGREDIENT | G59M7S0WS3 | NITRO-BID (NITROGLYCERIN) OINTMENT [SAVAGE LABORATORIES A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 7 | |
| nitroglycerin | ACTIVE MOIETY | G59M7S0WS3 | NITRO-BID (NITROGLYCERIN) OINTMENT [SAVAGE LABORATORIES A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 7 | |
| lactose | INACTIVE INGREDIENT | J2B2A4N98G | NITRO-BID (NITROGLYCERIN) OINTMENT [SAVAGE LABORATORIES A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 7 | |
| petrolatum | INACTIVE INGREDIENT | 4T6H12BN9U | NITRO-BID (NITROGLYCERIN) OINTMENT [SAVAGE LABORATORIES A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 7 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | NITRO-BID (NITROGLYCERIN) OINTMENT [SAVAGE LABORATORIES A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 7 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 207273 | NITRO-BID 2 % Topical Ointment | PSN | e464e9bb-48e8-4b9f-9fff-e220cfbac0c5 | 15 |
| 242946 | nitroglycerin 2 % Topical Ointment | PSN | e464e9bb-48e8-4b9f-9fff-e220cfbac0c5 | 15 |
| 207273 | nitroglycerin 0.02 MG/MG Topical Ointment [Nitro-Bid] | SBD | e464e9bb-48e8-4b9f-9fff-e220cfbac0c5 | 15 |
| 242946 | nitroglycerin 0.02 MG/MG Topical Ointment | SCD | e464e9bb-48e8-4b9f-9fff-e220cfbac0c5 | 15 |
| 207273 | Nitro-Bid 0.02 MG/MG Topical Ointment | SY | e464e9bb-48e8-4b9f-9fff-e220cfbac0c5 | 15 |
| 207273 | Nitro-Bid 2 % Topical Ointment | SY | e464e9bb-48e8-4b9f-9fff-e220cfbac0c5 | 15 |
| 207273 | Nitro-Bid 20 MG/GM Topical Ointment | SY | e464e9bb-48e8-4b9f-9fff-e220cfbac0c5 | 15 |
| 242946 | nitroglycerin 2 % Topical Ointment | SY | e464e9bb-48e8-4b9f-9fff-e220cfbac0c5 | 15 |
| 242946 | NTG 0.02 MG/MG Topical Ointment | SY | e464e9bb-48e8-4b9f-9fff-e220cfbac0c5 | 15 |
| 207273 | NTG 0.02 MG/MG Topical Ointment [Nitro-Bid] | SY | e464e9bb-48e8-4b9f-9fff-e220cfbac0c5 | 15 |
| 242946 | TNG 0.02 MG/MG Topical Ointment | SY | e464e9bb-48e8-4b9f-9fff-e220cfbac0c5 | 15 |
| 207273 | TNG 0.02 MG/MG Topical Ointment [Nitro-Bid] | SY | e464e9bb-48e8-4b9f-9fff-e220cfbac0c5 | 15 |
| 242946 | nitroglycerin 2 % Topical Ointment | PSN | 7da79fdf-0969-1ddd-e053-2991aa0a3ec4 | 4 |
| 242946 | nitroglycerin 0.02 MG/MG Topical Ointment | SCD | 7da79fdf-0969-1ddd-e053-2991aa0a3ec4 | 4 |
| 242946 | nitroglycerin 2 % Topical Ointment | SY | 7da79fdf-0969-1ddd-e053-2991aa0a3ec4 | 4 |
| 242946 | NTG 0.02 MG/MG Topical Ointment | SY | 7da79fdf-0969-1ddd-e053-2991aa0a3ec4 | 4 |
| 242946 | TNG 0.02 MG/MG Topical Ointment | SY | 7da79fdf-0969-1ddd-e053-2991aa0a3ec4 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0281-0326-08 | 00281032608 | 48 PACKET in 1 BOX (0281-0326-08) / 1 g in 1 PACKET | 48 packet | 2009-08-17 | 0000-00-00 | No | No | Current |
| 0281-0326-30 | 00281032630 | 30 g in 1 TUBE (0281-0326-30) | 30 g | 2009-08-17 | 0000-00-00 | No | No | Current |
| 0281-0326-60 | 00281032660 | 60 g in 1 TUBE (0281-0326-60) | 60 g | 2009-08-17 | 0000-00-00 | No | No | Current |