NITHIODOTE
- Product NDC
- 60267-812
- 11-digit product format
- 602670812
- Labeler code
- 60267
- Product ID
- 60267-812_74809468-0182-485a-bf62-e09489756a36
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Nitrite and Sodium Thiosulfate
- Dosage form
- KIT
- Labeler
- Hope Pharmaceuticals
- Application
- NDA201444
- Marketing category
- NDA
- Marketing start
- 2011-01-14
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NITHIODOTE
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 237832, 253010, 1086835, 1086836 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60267-311-10 | NITHIODOTE | 10 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 10 mL | 30 mg in 1mL | 10 |
| 60267-705-50 | NITHIODOTE | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 50 mL | 250 mg in 1mL | 10 |
| 60267-812-00 | NITHIODOTE | 1 in 1 CARTON | KIT | 1 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60267-812-00 | ML - Milliliter | 60267-812 | e69c10b0-705e-4bea-8055-3f4f8b62bc1a | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Sodium Nitrite | ACTIVE INGREDIENT | M0KG633D4F | NITHIODOTE (SODIUM NITRITE AND SODIUM THIOSULFATE) KIT [HOPE PHARMACEUTICALS] | 1 | |
| Sodium Thiosulfate | ACTIVE INGREDIENT | HX1032V43M | NITHIODOTE (SODIUM NITRITE AND SODIUM THIOSULFATE) KIT [HOPE PHARMACEUTICALS] | 1 | |
| Sodium Cation | ACTIVE MOIETY | LYR4M0NH37 | NITHIODOTE (SODIUM NITRITE AND SODIUM THIOSULFATE) KIT [HOPE PHARMACEUTICALS] | 1 | |
| Boric Acid | INACTIVE INGREDIENT | R57ZHV85D4 | NITHIODOTE (SODIUM NITRITE AND SODIUM THIOSULFATE) KIT [HOPE PHARMACEUTICALS] | 1 | |
| Potassium Chloride | INACTIVE INGREDIENT | 660YQ98I10 | NITHIODOTE (SODIUM NITRITE AND SODIUM THIOSULFATE) KIT [HOPE PHARMACEUTICALS] | 1 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | NITHIODOTE (SODIUM NITRITE AND SODIUM THIOSULFATE) KIT [HOPE PHARMACEUTICALS] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | NITHIODOTE (SODIUM NITRITE AND SODIUM THIOSULFATE) KIT [HOPE PHARMACEUTICALS] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1086836 | {1 (10 ML sodium nitrite 30 MG/ML Injection) / 1 (50 ML sodium thiosulfate 250 MG/ML Injection) } Pack [Nithiodote] | BPCK | ff4941b3-9901-4aab-adcf-c5327bede34e | 10 |
| 1086835 | {1 (10 ML sodium nitrite 30 MG/ML Injection) / 1 (50 ML sodium thiosulfate 250 MG/ML Injection) } Pack | GPCK | ff4941b3-9901-4aab-adcf-c5327bede34e | 10 |
| 1086836 | Nithiodote Pack | PSN | ff4941b3-9901-4aab-adcf-c5327bede34e | 10 |
| 253010 | sodium nitrite 300 MG in 10 ML Injection | PSN | ff4941b3-9901-4aab-adcf-c5327bede34e | 10 |
| 1086835 | sodium nitrite 300 MG in 10 ML Injection / sodium thiosulfate 12.5 GM in 50 ML Injection Pack | PSN | ff4941b3-9901-4aab-adcf-c5327bede34e | 10 |
| 237832 | sodium thiosulfate 12.5 GM in 50 ML Injection | PSN | ff4941b3-9901-4aab-adcf-c5327bede34e | 10 |
| 253010 | 10 ML sodium nitrite 30 MG/ML Injection | SCD | ff4941b3-9901-4aab-adcf-c5327bede34e | 10 |
| 237832 | 50 ML sodium thiosulfate 250 MG/ML Injection | SCD | ff4941b3-9901-4aab-adcf-c5327bede34e | 10 |
| 1086836 | Nithiodote Kit | SY | ff4941b3-9901-4aab-adcf-c5327bede34e | 10 |
| 1086835 | sodium nitrite 300 MG per 10 ML / sodium thiosulfate 12.5 GM per 50 ML Injection Kit | SY | ff4941b3-9901-4aab-adcf-c5327bede34e | 10 |
| 253010 | sodium nitrite 300 MG per 10 ML Injection | SY | ff4941b3-9901-4aab-adcf-c5327bede34e | 10 |
| 237832 | sodium thiosulfate 12.5 GM per 50 ML Injection | SY | ff4941b3-9901-4aab-adcf-c5327bede34e | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 60267-311-10 | 60267031110 | 10 mL in 1 VIAL, SINGLE-USE | 10 ml | Historical | ||||
| 60267-705-50 | 60267070550 | 50 mL in 1 VIAL, SINGLE-DOSE | 50 ml | Historical | ||||
| 60267-812-00 | 60267081200 | 1 KIT in 1 CARTON (60267-812-00) * 10 mL in 1 VIAL, SINGLE-USE (60267-311-10) * 50 mL in 1 VIAL, SINGLE-DOSE (60267-705-50) | 1 kit | 2011-01-14 | 0000-00-00 | No | No | Current |