Ketotifen Fumarate
- Product NDC
- 59779-330
- 11-digit product format
- 597790330
- Labeler code
- 59779
- Product ID
- 59779-330_afed3c93-e95a-49e1-9e44-fc69c14d1173
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ketotifen Fumarate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- CVS Pharmacy
- Application
- ANDA077958
- Marketing category
- ANDA
- Marketing start
- 2013-02-21
- 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 |
|---|---|---|---|---|---|
| 59779-330-01 | 2024-01-30 | C162847 | 48780-1 | 9d75b9d0-cc6a-f424-e053-dadaa90a57ce | 9d4d00c3-1bb3-46a9-9ad3-7ec26c500770 |
| 59779-330-02 | 2024-01-30 | C162847 | 48780-1 | 1030e365-367f-111a-e063-dadaa90a10e2 | 3057eccb-97ff-43c0-9669-ded7d50bc143 |
| 59779-330-01 | 2020-10-26 | C162847 | 48780-1 | 9d75b9d0-cc6a-f424-e053-dadaa90a57ce | 9d4d00c3-1bb3-46a9-9ad3-7ec26c500770 |
| 59779-330-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cc6a-f424-e053-dadaa90a57ce | 9d4d00c3-1bb3-46a9-9ad3-7ec26c500770 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59779-330-01 | Ketotifen Fumarate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 8 | |
| 59779-330-01 | Ketotifen Fumarate | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | 8 | |
| 59779-330-02 | Ketotifen Fumarate | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | 6 | |
| 59779-330-02 | Ketotifen Fumarate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59779-330-01 | ML - Milliliter | 59779-330 | a0d3c218-2808-4740-b89e-1873d6b6ccd9 | 1 | 2018-07-03 |
| 59779-330-02 | ML - Milliliter | 59779-330 | 684b4456-a6f8-4442-892e-1e7239c6bafc | 1 | 2022-06-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59779-330 | KETOTIFEN FUMARATE SOLUTION/ DROPS [CVS PHARMACY] | 8 | Legacy NDC, 2 package rows | 20220211_9d4d00c3-1bb3-46a9-9ad3-7ec26c500770.zip |
| 59779-330 | KETOTIFEN FUMARATE SOLUTION/ DROPS [CVS PHARMACY] | 6 | Legacy NDC, 2 package rows | 20220125_3057eccb-97ff-43c0-9669-ded7d50bc143.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311237 | ketotifen 0.025 % Ophthalmic Solution | PSN | 9d4d00c3-1bb3-46a9-9ad3-7ec26c500770 | 8 |
| 311237 | ketotifen 0.25 MG/ML Ophthalmic Solution | SCD | 9d4d00c3-1bb3-46a9-9ad3-7ec26c500770 | 8 |
| 311237 | ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution | SY | 9d4d00c3-1bb3-46a9-9ad3-7ec26c500770 | 8 |
| 311237 | ketotifen 0.025 % Ophthalmic Solution | SY | 9d4d00c3-1bb3-46a9-9ad3-7ec26c500770 | 8 |
| 311237 | ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution | SY | 9d4d00c3-1bb3-46a9-9ad3-7ec26c500770 | 8 |
| 311237 | ketotifen 0.025 % Ophthalmic Solution | PSN | 3057eccb-97ff-43c0-9669-ded7d50bc143 | 6 |
| 311237 | ketotifen 0.25 MG/ML Ophthalmic Solution | SCD | 3057eccb-97ff-43c0-9669-ded7d50bc143 | 6 |
| 311237 | ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution | SY | 3057eccb-97ff-43c0-9669-ded7d50bc143 | 6 |
| 311237 | ketotifen 0.025 % Ophthalmic Solution | SY | 3057eccb-97ff-43c0-9669-ded7d50bc143 | 6 |
| 311237 | ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution | SY | 3057eccb-97ff-43c0-9669-ded7d50bc143 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 59779-330-01 | 59779033001 | 1 BOTTLE, DROPPER in 1 CARTON (59779-330-01) > 10 mL in 1 BOTTLE, DROPPER | 2013-02-21 | 0000-00-00 | No | No | Current |
| 59779-330-02 | 59779033002 | 1 BOTTLE, DROPPER in 1 CARTON (59779-330-02) > 10 mL in 1 BOTTLE, DROPPER | 2013-10-11 | 0000-00-00 | No | No | Current |