SEMPREX
- Product NDC
- 52244-404
- 11-digit product format
- 522440404
- Labeler code
- 52244
- Product ID
- 52244-404_21d2a8a6-108c-4c1d-b1ee-c14f6f2dadc6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acrivastine and pseudoephedrine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Endo Pharmaceuticals Inc.
- Application
- NDA019806
- Marketing category
- NDA
- Marketing start
- 2012-01-26
- Marketing end
- 2020-12-31
- Substance
- ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 8 mg/1; mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 52244-404 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 52244-404 | 52244-404-10 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| N019806-001 | SEMPREX-D | ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE | 8MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | | RLD | 1994-03-25 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACRIVASTINE | ACTIVE INGREDIENT | A20F9XAI7W | SEMPREX D (ACRIVASTINE AND PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULE [ACTIENT PHARMACEUTICALS, LLC] | 4 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | SEMPREX D (ACRIVASTINE AND PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULE [ACTIENT PHARMACEUTICALS, LLC] | 4 | |
| ACRIVASTINE | ACTIVE MOIETY | A20F9XAI7W | SEMPREX D (ACRIVASTINE AND PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULE [ACTIENT PHARMACEUTICALS, LLC] | 4 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | SEMPREX D (ACRIVASTINE AND PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULE [ACTIENT PHARMACEUTICALS, LLC] | 4 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | SEMPREX D (ACRIVASTINE AND PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULE [ACTIENT PHARMACEUTICALS, LLC] | 4 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | SEMPREX D (ACRIVASTINE AND PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULE [ACTIENT PHARMACEUTICALS, LLC] | 4 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | SEMPREX D (ACRIVASTINE AND PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULE [ACTIENT PHARMACEUTICALS, LLC] | 4 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | SEMPREX D (ACRIVASTINE AND PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULE [ACTIENT PHARMACEUTICALS, LLC] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SEMPREX D (ACRIVASTINE AND PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULE [ACTIENT PHARMACEUTICALS, LLC] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SEMPREX D (ACRIVASTINE AND PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULE [ACTIENT PHARMACEUTICALS, LLC] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SEMPREX D (ACRIVASTINE AND PSEUDOEPHEDRINE HYDROCHLORIDE) CAPSULE [ACTIENT PHARMACEUTICALS, LLC] | 4 | |