Ketotifen Fumarate
- Product NDC
- 17478-717
- 11-digit product format
- 174780717
- Labeler code
- 17478
- Product ID
- 17478-717_730d47be-f8fa-45a4-829d-e8b43c850c44
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ketotifen Fumarate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Akorn
- Application
- ANDA077958
- Marketing category
- ANDA
- Marketing start
- 2007-10-01
- Marketing end
- 0000-00-00
- Substance
- KETOTIFEN FUMARATE
- Active strength
- 0 mg/mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
- 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 |
|---|---|---|---|
| fa9ae9d1-ed96-4d6e-8814-0a4815bc3229 | Product name | 1 | 20221208 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17478-717-10 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2b57-111a-e063-dadaa90a10e2 | 1376a697-bcf3-47a4-ba0d-8be7aa395c56 |
| 17478-717-11 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2b57-111a-e063-dadaa90a10e2 | 1376a697-bcf3-47a4-ba0d-8be7aa395c56 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17478-717-10 | Ketotifen Fumarate | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | 9 | |
| 17478-717-10 | Ketotifen Fumarate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 9 | |
| 17478-717-11 | Ketotifen Fumarate | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | 9 | |
| 17478-717-11 | Ketotifen Fumarate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17478-717-10 | ML - Milliliter | 17478-717 | ce0e369a-3af1-4d5f-acd2-f493a3cfb1a6 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Ketotifen Fumarate | ACTIVE INGREDIENT | HBD503WORO | KETOTIFEN FUMARATE SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Ketotifen | ACTIVE MOIETY | X49220T18G | KETOTIFEN FUMARATE SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Benzalkonium Chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | KETOTIFEN FUMARATE SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | KETOTIFEN FUMARATE SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Hydrochloric Acid | INACTIVE INGREDIENT | QTT17582CB | KETOTIFEN FUMARATE SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | KETOTIFEN FUMARATE SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | KETOTIFEN FUMARATE SOLUTION/ DROPS [AKORN, INC.] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311237 | ketotifen 0.025 % Ophthalmic Solution | PSN | 1376a697-bcf3-47a4-ba0d-8be7aa395c56 | 9 |
| 311237 | ketotifen 0.25 MG/ML Ophthalmic Solution | SCD | 1376a697-bcf3-47a4-ba0d-8be7aa395c56 | 9 |
| 311237 | ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution | SY | 1376a697-bcf3-47a4-ba0d-8be7aa395c56 | 9 |
| 311237 | ketotifen 0.025 % Ophthalmic Solution | SY | 1376a697-bcf3-47a4-ba0d-8be7aa395c56 | 9 |
| 311237 | ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution | SY | 1376a697-bcf3-47a4-ba0d-8be7aa395c56 | 9 |
| 311237 | ketotifen 0.025 % Ophthalmic Solution | PSN | 3a9e70ab-d188-488c-8c47-a2184eb4ef2c | 3 |
| 311237 | ketotifen 0.25 MG/ML Ophthalmic Solution | SCD | 3a9e70ab-d188-488c-8c47-a2184eb4ef2c | 3 |
| 311237 | ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution | SY | 3a9e70ab-d188-488c-8c47-a2184eb4ef2c | 3 |
| 311237 | ketotifen 0.025 % Ophthalmic Solution | SY | 3a9e70ab-d188-488c-8c47-a2184eb4ef2c | 3 |
| 311237 | ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution | SY | 3a9e70ab-d188-488c-8c47-a2184eb4ef2c | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 17478-717-10 | 17478071710 | 1 BOTTLE, DROPPER in 1 CARTON (17478-717-10) > 5 mL in 1 BOTTLE, DROPPER | 2007-10-01 | 0000-00-00 | No | No | Current |
| 17478-717-11 | 17478071711 | 1 BOTTLE, DROPPER in 1 CARTON (17478-717-11) > 10 mL in 1 BOTTLE, DROPPER | 2016-09-30 | 0000-00-00 | No | No | Current |