Cetirizine Hydrochloride
- Product NDC
- 71335-9612
- 11-digit product format
- 713359612
- Labeler code
- 71335
- Product ID
- 71335-9612_feff9aa9-70f0-4e25-a822-f219cd1dde9a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride Tablets
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078343
- Marketing category
- ANDA
- Marketing start
- 2018-12-17
- 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 |
|---|
| 71335-9612-1 | Cetirizine Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 102 |
| 71335-9612-2 | Cetirizine Hydrochloride | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 102 |
| 71335-9612-3 | Cetirizine Hydrochloride | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 102 |
| 71335-9612-4 | Cetirizine Hydrochloride | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 102 |
| 71335-9612-5 | Cetirizine Hydrochloride | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 102 |
| 71335-9612-6 | Cetirizine Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 102 |
| 71335-9612-7 | Cetirizine Hydrochloride | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 102 |
| 71335-9612-8 | Cetirizine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 102 |
| 71335-9612-9 | Cetirizine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 102 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-9612 | CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [BRYANT RANCH PREPACK] | 101 | Current NDC, Legacy NDC, 9 package rows | 20240726_e4324124-13f8-4450-9fd6-686bd6e25578.zip |
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 |
|---|
| 71335-9612-1 | 71335961201 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9612-1) | 2023-01-03 | 0000-00-00 | No | No | Current |
| 71335-9612-2 | 71335961202 | 14 TABLET, FILM COATED in 1 BOTTLE (71335-9612-2) | 2023-01-03 | 0000-00-00 | No | No | Current |
| 71335-9612-3 | 71335961203 | 7 TABLET, FILM COATED in 1 BOTTLE (71335-9612-3) | 2023-01-03 | 0000-00-00 | No | No | Current |
| 71335-9612-4 | 71335961204 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-9612-4) | 2023-01-03 | 0000-00-00 | No | No | Current |
| 71335-9612-5 | 71335961205 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-9612-5) | 2023-01-03 | 0000-00-00 | No | No | Current |
| 71335-9612-6 | 71335961206 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-9612-6) | 2023-01-03 | 0000-00-00 | No | No | Current |
| 71335-9612-7 | 71335961207 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-9612-7) | 2023-01-03 | 0000-00-00 | No | No | Current |
| 71335-9612-8 | 71335961208 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-9612-8) | 2023-01-03 | 0000-00-00 | No | No | Current |
| 71335-9612-9 | 71335961209 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-9612-9) | 2023-01-03 | 0000-00-00 | No | No | Current |