Cetirizine Hydrochloride
- Product NDC
- 68016-939
- 11-digit product format
- 680160939
- Labeler code
- 68016
- Product ID
- 68016-939_62e359b6-7269-4672-9db1-0e9abc63afb3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chain Drug Consortium, LLC
- Application
- ANDA077498
- Marketing category
- ANDA
- Marketing start
- 2007-12-27
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cetirizine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014678 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68016-939-30 | Cetirizine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 68016-939-54 | Cetirizine Hydrochloride | 14 in 1 BLISTER PACK | TABLET | 14 | | 4 |
| 68016-939-60 | Cetirizine Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 4 |
| 68016-939-90 | Cetirizine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CETIRIZINE HYDROCHLORIDE | ACTIVE INGREDIENT | 64O047KTOA | CETIRIZINE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC] | 3 | |
| CETIRIZINE | ACTIVE MOIETY | YO7261ME24 | CETIRIZINE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CETIRIZINE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CETIRIZINE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CETIRIZINE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CETIRIZINE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC] | 3 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | CETIRIZINE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CETIRIZINE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CETIRIZINE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CETIRIZINE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68016-939 | CETIRIZINE HYDROCHLORIDE TABLET [CHAIN DRUG CONSORTIUM, LLC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20180829_9d7d2342-a594-4851-810b-b7bce1bd07dc.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 |
|---|
| 68016-939-30 | 68016093930 | 30 TABLET in 1 BOTTLE (68016-939-30) | 30 tablet | 2007-12-27 | 0000-00-00 | No | No | Current |
| 68016-939-54 | 68016093954 | 14 TABLET in 1 BLISTER PACK (68016-939-54) | 14 tablet | 2007-12-27 | 0000-00-00 | No | No | Current |
| 68016-939-60 | 68016093960 | 60 TABLET in 1 BOTTLE (68016-939-60) | 60 tablet | 2007-12-27 | 0000-00-00 | No | No | Current |
| 68016-939-90 | 68016093990 | 90 TABLET in 1 BOTTLE (68016-939-90) | 90 tablet | 2007-12-27 | 0000-00-00 | No | No | Current |