CETIRIZINE HYDROCHLORIDE
- Product NDC
- 16714-271
- 11-digit product format
- 167140271
- Labeler code
- 16714
- Product ID
- 16714-271_8807545d-1d6b-4360-b7ad-30bf2321766a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CETIRIZINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northstar Rx LLC
- Application
- ANDA078862
- Marketing category
- ANDA
- Marketing start
- 2009-10-19
- Marketing end
- 2021-08-31
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CETIRIZINE HYDROCHLORIDE | ACTIVE INGREDIENT | 64O047KTOA | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] | 1 | |
| CETIRIZINE | ACTIVE MOIETY | YO7261ME24 | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] | 1 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16714-271-02 | 16714027102 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-271-02) | 2009-10-19 | 2021-08-31 | No | No | Current |
| 16714-271-03 | 16714027103 | 300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-271-03) | 2009-10-19 | 2021-08-31 | No | No | Current |