Cetirizine Hydrochloride
- Product NDC
- 55111-699
- 11-digit product format
- 551110699
- Labeler code
- 55111
- Product ID
- 55111-699_000d3a47-3836-b678-9487-2bbc518cd57f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr.Reddy's Laboratories Limited
- Application
- ANDA078343
- Marketing category
- ANDA
- Marketing start
- 2008-01-15
- 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 Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CETIRIZINE HYDROCHLORIDE | ACTIVE INGREDIENT | 64O047KTOA | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 5 | |
| CETIRIZINE | ACTIVE MOIETY | YO7261ME24 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 5 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 5 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-699 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 8 | Current NDC, Legacy NDC | 20250321_de152651-bfcd-856a-8329-a2ac93a376bc.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 |
|---|
| 55111-699-04 | 55111069904 | 1 BOTTLE in 1 CARTON (55111-699-04) / 120 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2008-04-11 | 0000-00-00 | No | No | Current |
| 55111-699-15 | 55111069915 | 1 BLISTER PACK in 1 CARTON (55111-699-15) / 14 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2008-04-04 | 0000-00-00 | No | No | Current |
| 55111-699-19 | 55111069919 | 1 BOTTLE in 1 CARTON (55111-699-19) / 175 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2008-01-15 | 0000-00-00 | No | No | Current |
| 55111-699-30 | 55111069930 | 1 BOTTLE in 1 CARTON (55111-699-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2008-04-03 | 0000-00-00 | No | No | Current |
| 55111-699-31 | 55111069931 | 1 BOTTLE in 1 CARTON (55111-699-31) / 300 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2016-09-27 | 0000-00-00 | No | No | Current |
| 55111-699-45 | 55111069945 | 1 BOTTLE in 1 CARTON (55111-699-45) / 45 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2008-04-08 | 0000-00-00 | No | No | Current |
| 55111-699-47 | 55111069947 | 2 BOTTLE in 1 CARTON (55111-699-47) / 175 TABLET, FILM COATED in 1 BOTTLE | 2 bottle | 2008-04-03 | 0000-00-00 | No | No | Current |
| 55111-699-51 | 55111069951 | 1 BOTTLE in 1 CARTON (55111-699-51) / 75 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2008-07-22 | 0000-00-00 | No | No | Current |
| 55111-699-52 | 55111069952 | 1 BOTTLE in 1 CARTON (55111-699-52) / 14 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2010-10-06 | 0000-00-00 | No | No | Current |
| 55111-699-60 | 55111069960 | 1 BOTTLE in 1 CARTON (55111-699-60) / 60 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2008-04-07 | 0000-00-00 | No | No | Current |
| 55111-699-73 | 55111069973 | 1 BOTTLE in 1 CARTON (55111-699-73) / 365 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2010-10-06 | 0000-00-00 | No | No | Current |
| 55111-699-74 | 55111069974 | 2 BLISTER PACK in 1 CARTON (55111-699-74) / 7 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2008-04-04 | 0000-00-00 | No | No | Current |
| 55111-699-90 | 55111069990 | 90 TABLET, FILM COATED in 1 BOTTLE (55111-699-90) | | 2008-04-08 | 0000-00-00 | No | No | Current |