OLOPATADINE HYDROCHLORIDE
- Product NDC
- 53002-0510
- 11-digit product format
- 530020510
- Labeler code
- 53002
- Product ID
- 53002-0510_a74d1800-2b21-4d30-bda3-afa71291eb28
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OLOPATADINE HYDROCHLORIDE
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- RPK Pharmaceuticals, 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 Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-0510-1 | OLOPATADINE HYDROCHLORIDE | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-0510 | OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 1 package rows | 20230609_c8c44b45-b69b-4ba9-bc4f-ce43e260a4b6.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 |
|---|
| 53002-0510-1 | 53002051001 | 5 mL in 1 BOTTLE, DROPPER (53002-0510-1) | 5 ml | 2019-06-01 | 0000-00-00 | No | No | Current |