Alaway
- Product NDC
- 24208-601
- 11-digit product format
- 242080601
- Labeler code
- 24208
- Product ID
- 24208-601_4f27a942-b5f3-4a01-8022-49deced585f8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ketotifen Fumarate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Bausch & Lomb Incorporated
- Application
- NDA021996
- Marketing category
- NDA
- Marketing start
- 2006-12-01
- Substance
- KETOTIFEN FUMARATE
- Active strength
- .25 mg/mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Alaway
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| KETOTIFEN FUMARATE | .25 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | HBD503WORO |
| Rxcui | 311237, 707594 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fa9ae9d1-ed96-4d6e-8814-0a4815bc3229 | Product name | 1 | 20221208 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 24208-601-05 | Alaway | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | 15 | |
| 24208-601-05 | Alaway | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 15 | |
| 24208-601-10 | Alaway | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 15 | |
| 24208-601-10 | Alaway | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | 15 | |
| 24208-601-90 | Alaway | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | 15 | |
| 24208-601-90 | Alaway | 2 in 1 CARTON | SOLUTION/ DROPS | 2 | 15 | |
| 24208-601-95 | Alaway | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 15 | |
| 24208-601-95 | Alaway | 1 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 1 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 24208-601-05 | ML - Milliliter | 24208-601 | 70e262e3-9f7f-4665-a66e-102f74ef9ad2 | 1 | 2014-05-02 |
| 24208-601-10 | ML - Milliliter | 24208-601 | 210a1fc5-ef5f-4d05-a59b-769c7b5c1bd1 | 1 | 2012-07-24 |
| 24208-601-90 | ML - Milliliter | 24208-601 | 8b54b237-79e9-4a15-8081-78eb258b09de | 1 | 2025-11-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| KETOTIFEN FUMARATE | ACTIVE INGREDIENT | HBD503WORO | ALAWAY (KETOTIFEN FUMARATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] | 8 | |
| KETOTIFEN | ACTIVE MOIETY | X49220T18G | ALAWAY (KETOTIFEN FUMARATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] | 8 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | ALAWAY (KETOTIFEN FUMARATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] | 8 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | ALAWAY (KETOTIFEN FUMARATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] | 8 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | ALAWAY (KETOTIFEN FUMARATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] | 8 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | ALAWAY (KETOTIFEN FUMARATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] | 8 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ALAWAY (KETOTIFEN FUMARATE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] | 8 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 707594 | Alaway 0.025 % Ophthalmic Solution | PSN | e4c310b5-1dba-4ddc-bc90-b27ebc765871 | 15 |
| 311237 | ketotifen 0.025 % Ophthalmic Solution | PSN | e4c310b5-1dba-4ddc-bc90-b27ebc765871 | 15 |
| 707594 | ketotifen 0.25 MG/ML Ophthalmic Solution [Alaway] | SBD | e4c310b5-1dba-4ddc-bc90-b27ebc765871 | 15 |
| 311237 | ketotifen 0.25 MG/ML Ophthalmic Solution | SCD | e4c310b5-1dba-4ddc-bc90-b27ebc765871 | 15 |
| 707594 | Alaway 0.025 % Ophthalmic Solution | SY | e4c310b5-1dba-4ddc-bc90-b27ebc765871 | 15 |
| 311237 | ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic Solution | SY | e4c310b5-1dba-4ddc-bc90-b27ebc765871 | 15 |
| 311237 | ketotifen 0.025 % Ophthalmic Solution | SY | e4c310b5-1dba-4ddc-bc90-b27ebc765871 | 15 |
| 311237 | ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic Solution | SY | e4c310b5-1dba-4ddc-bc90-b27ebc765871 | 15 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 24208-601-05 | 24208060105 | 1 BOTTLE, DROPPER in 1 CARTON (24208-601-05) / 5 mL in 1 BOTTLE, DROPPER | 2006-12-01 | 0000-00-00 | No | No | Current |
| 24208-601-10 | 24208060110 | 1 BOTTLE, DROPPER in 1 CARTON (24208-601-10) / 10 mL in 1 BOTTLE, DROPPER | 2006-12-01 | 0000-00-00 | No | No | Current |
| 24208-601-90 | 24208060190 | 2 BOTTLE, DROPPER in 1 CARTON (24208-601-90) / 10 mL in 1 BOTTLE, DROPPER | 2006-12-01 | 0000-00-00 | No | No | Current |
| 24208-601-95 | 24208060195 | 1 in 1 CARTON | Historical |