Olopatadine Hydrochloride
- Product NDC
- 50383-943
- 11-digit product format
- 503830943
- Labeler code
- 50383
- Product ID
- 50383-943_6f46b6ea-b467-46c0-b3e3-1fb14e8cafd1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olopatadine Hydrochloride Nasal
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Akorn
- Application
- ANDA213757
- Marketing category
- ANDA
- Marketing start
- 2020-09-29
- Marketing end
- 0000-00-00
- Substance
- OLOPATADINE HYDROCHLORIDE
- Active strength
- 665 ug/1
- 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
- 2024-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50383-943 | OLOPATADINE HYDROCHLORIDE (OLOPATADINE HYDROCHLORIDE NASAL) SPRAY, METERED [AKORN] | 7 | Legacy NDC | 20230112_f42d26f8-c583-411b-b17f-b3ca9eaba7a2.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50383-943-23 | 50383094323 | 1 BOTTLE in 1 CARTON (50383-943-23) > 240 SPRAY, METERED in 1 BOTTLE | 1 bottle | 2020-09-29 | 0000-00-00 | No | No | Current |