PREDNISOLONE ACETATE
- Product NDC
- 52959-265
- 11-digit product format
- 529590265
- Labeler code
- 52959
- Product ID
- 52959-265_fceefb90-8d05-40f0-b612-107685339aff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- prednisolone acetate
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- H.J. Harkins Company, Inc.
- Application
- NDA017011
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 1997-08-19
- Marketing end
- 0000-00-00
- Substance
- PREDNISOLONE ACETATE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52959-265-05 | PREDNISOLONE ACETATE | 5 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 5 | | 3 |
| 52959-265-10 | PREDNISOLONE ACETATE | 10 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 10 | | 3 |
| 52959-265-15 | PREDNISOLONE ACETATE | 15 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 15 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| prednisolone acetate | ACTIVE INGREDIENT | 8B2807733D | PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] | 3 | |
| prednisolone | ACTIVE MOIETY | 9PHQ9Y1OLM | PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] | 3 | |
| benzalkonium chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] | 3 | |
| boric acid | INACTIVE INGREDIENT | R57ZHV85D4 | PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] | 3 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] | 3 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] | 3 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] | 3 | |
| sodium bisulfite | INACTIVE INGREDIENT | TZX5469Z6I | PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] | 3 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] | 3 | |
| sodium citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] | 3 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52959-265 | PREDNISOLONE ACETATE SUSPENSION/ DROPS [H.J. HARKINS COMPANY, INC.] | 3 | Legacy NDC, 3 package rows | 20111118_c77597c4-8add-4d2a-b8c1-e526cbe22dcb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 52959-265-05 | 52959026505 | 5 mL in 1 BOTTLE, DROPPER | 5 ml | Historical |
| 52959-265-10 | 52959026510 | 10 mL in 1 BOTTLE, DROPPER | 10 ml | Historical |
| 52959-265-15 | 52959026515 | 15 mL in 1 BOTTLE, DROPPER | 15 ml | Historical |