Olopatadine
- Product NDC
- 17478-305
- 11-digit product format
- 174780305
- Labeler code
- 17478
- Product ID
- 17478-305_2ac51981-3e1f-48ef-a58c-efca48a81549
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olopatadine Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Akorn
- Application
- ANDA204723
- Marketing category
- ANDA
- Marketing start
- 2017-12-05
- Marketing end
- 0000-00-00
- Substance
- OLOPATADINE HYDROCHLORIDE
- Active strength
- 2 mg/mL
- 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
- 2023-12-31
- 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 |
|---|
| 17478-305-12 | Olopatadine | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 3 |
| 17478-305-12 | Olopatadine | 2.5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 2.5 | | 3 |
| 17478-305-11 | Olopatadine | 2.5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 2.5 | | 2 |
| 17478-305-11 | Olopatadine | 2 in 1 CARTON | SOLUTION/ DROPS | 2 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17478-305 | OLOPATADINE (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [AKORN] | 3 | Legacy NDC, 2 package rows | 20220204_7de7f9ea-53e3-4f03-b60d-31a2817b5f49.zip |
| 17478-305 | OLOPATADINE (OLOPATADINE HYDROCHLORIDE) SOLUTION/ DROPS [AKORN] | 2 | Legacy NDC, 2 package rows | 20220204_138f0f62-c5d2-457c-8a29-c44fd84aefde.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 17478-305-11 | 17478030511 | 2 BOTTLE, DROPPER in 1 CARTON (17478-305-11) > 2.5 mL in 1 BOTTLE, DROPPER | 2021-09-01 | 0000-00-00 | No | No | Current |
| 17478-305-12 | 17478030512 | 1 BOTTLE, DROPPER in 1 CARTON (17478-305-12) > 2.5 mL in 1 BOTTLE, DROPPER | 2017-12-05 | 0000-00-00 | No | No | Current |