FLUOROMETHOLONE
- Product NDC
- 60758-880
- 11-digit product format
- 607580880
- Labeler code
- 60758
- Product ID
- 60758-880_6dbbb0d9-cddb-4634-8273-e70e54ea4a38
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluorometholone
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Pacific Pharma, Inc.
- Application
- NDA016851
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 1997-10-31
- Substance
- FLUOROMETHOLONE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FLUOROMETHOLONE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOROMETHOLONE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SV0CSG527L |
| Rxcui | 310377 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60758-880-05 | FLUOROMETHOLONE | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 10 |
| 60758-880-05 | FLUOROMETHOLONE | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 10 |
| 60758-880-10 | FLUOROMETHOLONE | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 10 |
| 60758-880-10 | FLUOROMETHOLONE | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 10 |
| 60758-880-15 | FLUOROMETHOLONE | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | | 10 |
| 60758-880-15 | FLUOROMETHOLONE | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| fluorometholone | ACTIVE INGREDIENT | SV0CSG527L | FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 3 | |
| fluorometholone | ACTIVE MOIETY | SV0CSG527L | FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 3 | |
| benzalkonium chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 3 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 3 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 3 | |
| polyvinyl alcohol | INACTIVE INGREDIENT | 532B59J990 | FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 3 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 3 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 3 | |
| sodium phosphate, dibasic | INACTIVE INGREDIENT | GR686LBA74 | FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 3 | |
| sodium phosphate, monobasic | INACTIVE INGREDIENT | 3980JIH2SW | FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 3 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60758-880 | FLUOROMETHOLONE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 9 | Current NDC, Legacy NDC, 6 package rows | 20231114_af59c420-789d-4c05-b3fc-c3f855bcac24.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60758-880-05 | 60758088005 | 1 BOTTLE, DROPPER in 1 CARTON (60758-880-05) / 5 mL in 1 BOTTLE, DROPPER | | 1997-10-31 | 0000-00-00 | No | No | Current |
| 60758-880-10 | 60758088010 | 1 BOTTLE, DROPPER in 1 CARTON (60758-880-10) / 10 mL in 1 BOTTLE, DROPPER | | 1997-10-31 | 0000-00-00 | No | No | Current |
| 60758-880-15 | 60758088015 | 15 mL in 1 BOTTLE, DROPPER | 15 ml | | | | | Historical |