Olopatadine Hydrochloride
- Product NDC
- 0378-8023
- 11-digit product format
- 003788023
- Labeler code
- 0378
- Product ID
- 0378-8023_520e4d29-c420-4dc6-84c2-5dbb75670442
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olopatadine Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA204392
- Marketing category
- ANDA
- Marketing start
- 2018-09-12
- Marketing end
- 2021-12-31
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-8023-35 | 00378802335 | 1 BOTTLE, DROPPER in 1 CARTON (0378-8023-35) > 5 mL in 1 BOTTLE, DROPPER | 2018-09-12 | 2021-12-31 | No | No | Current |