OLOPATADINE HYDROCHLORIDE
- Product NDC
- 76420-089
- 11-digit product format
- 764200089
- Labeler code
- 76420
- Product ID
- 76420-089_b26a17f3-e137-3c74-e053-2a95a90af65b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OLOPATADINE HYDROCHLORIDE
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA206306
- Marketing category
- ANDA
- Marketing start
- 2015-12-07
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-089 | OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS [ASCLEMED USA, INC.] | 1 | Legacy NDC | 20201027_bf918e61-e0fd-41a0-b931-dec84e978f04.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76420-089-05 | 76420008905 | 5 mL in 1 BOTTLE (76420-089-05) | 5 ml | 2020-10-24 | 0000-00-00 | No | No | Current |