Fexofenadine HCl and Pseudoephedrine HCl
- Product NDC
- 43598-892
- 11-digit product format
- 435980892
- Labeler code
- 43598
- Product ID
- 43598-892_4eb8619f-5163-2d01-d21d-dec85bc67ab6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine HCl and Pseudoephedrine HCl
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Dr.Reddy's Laboratories Inc
- Application
- ANDA079043
- Marketing category
- ANDA
- Marketing start
- 2022-05-17
- Marketing end
- 2026-08-31
- Substance
- FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 180; 240 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fexofenadine HCl and Pseudoephedrine HCl
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FEXOFENADINE HYDROCHLORIDE | 180 mg/1 |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 240 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S068B75ZU, 6V9V2RYJ8N |
| Rxcui | 997415 |
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-892 | FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES INC] | 2 | Current NDC, Legacy NDC | 20240131_d4e66d84-5ce8-36a1-7a99-2a2a0f38ce19.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 |
|---|
| 43598-892-07 | 43598089207 | 1 BLISTER PACK in 1 CARTON (43598-892-07) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2022-05-17 | 0000-00-00 | No | No | Current |
| 43598-892-29 | 43598089229 | 3 BLISTER PACK in 1 CARTON (43598-892-29) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 3 blister pack | 2022-05-17 | 2026-07-30 | No | No | Current |
| 43598-892-35 | 43598089235 | 2 BLISTER PACK in 1 CARTON (43598-892-35) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2 blister pack | 2022-05-17 | 2026-08-31 | No | No | Current |