OLOPATADINE HYDROCHLORIDE
- Product NDC
- 76519-1161
- 11-digit product format
- 765191161
- Labeler code
- 76519
- Product ID
- 76519-1161_91466fe8-f0ce-084d-e053-2a95a90ae655
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OLOPATADINE HYDROCHLORIDE
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- H.J. Harkins Company, Inc.
- Application
- ANDA206306
- Marketing category
- ANDA
- Marketing start
- 2018-10-31
- Marketing end
- 0000-00-00
- Substance
- OLOPATADINE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Decreased Histamine Release [PE],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|
| 76519-1161-0 | OLOPATADINE HYDROCHLORIDE | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76519-1161 | OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] | 1 | Legacy NDC, 1 package rows | 20190831_91466fe8-f0cd-084d-e053-2a95a90ae655.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 |
|---|
| 76519-1161-0 | 76519116100 | 5 mL in 1 BOTTLE (76519-1161-0) | 5 ml | 2018-10-31 | 0000-00-00 | No | No | Current |