Loratadine and Pseudoephedrine
- Product NDC
- 70518-0653
- 11-digit product format
- 705180653
- Labeler code
- 70518
- Product ID
- 70518-0653_e20a3338-3fcc-f984-e053-2a95a90a0693
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- loratadine and pseudoephedrine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA076557
- Marketing category
- ANDA
- Marketing start
- 2017-07-31
- Marketing end
- 0000-00-00
- Substance
- LORATADINE; PSEUDOEPHEDRINE SULFATE
- Active strength
- 10 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-0653-0 | 70518065300 | 5 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-0653-0) | | 2017-07-31 | 0000-00-00 | No | No | Current |
| 70518-0653-1 | 70518065301 | 1 BLISTER PACK in 1 CARTON (70518-0653-1) > 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2021-09-10 | 0000-00-00 | No | No | Current |