Retaine Allergy
- Product NDC
- 54799-920
- 11-digit product format
- 547990920
- Labeler code
- 54799
- Product ID
- 54799-920_575c94a5-ec98-4050-a450-2a6c4ef95641
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- olopatadine hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- OCuSOFT LLC
- Application
- ANDA209420
- Marketing category
- ANDA
- Marketing start
- 2024-07-05
- Substance
- OLOPATADINE HYDROCHLORIDE
- Active strength
- 5 mg/2.5mL
- Pharmacologic classes
- Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Retaine Allergy
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OLOPATADINE HYDROCHLORIDE | 5 mg/2.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2XG66W44KF |
| Rxcui | 1111343 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54799-920-25 | Retaine Allergy | 2.5 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 2.5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54799-920 | RETAINE ALLERGY (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [OCUSOFT INC.] | 1 | Current NDC, 1 package rows | 20240707_e0a01606-275d-448c-8838-ca46f1e612e5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 54799-920-25 | 54799092025 | 2.5 mL in 1 BOTTLE, PLASTIC (54799-920-25) | 2.5 ml | 2024-07-05 | No | No | Historical |