BERKLEY AND JENSEN ALL DAY ALLERGY
- Product NDC
- 68391-400
- 11-digit product format
- 683910400
- Labeler code
- 68391
- Product ID
- 68391-400_09c3300a-a96f-4967-aa1d-85b6e9fd5798
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- BJWC
- Application
- ANDA078336
- Marketing category
- ANDA
- Marketing start
- 2025-09-04
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BERKLEY AND JENSEN ALL DAY ALLERGY
- Listing expiration
- 2027-12-31
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 |
|---|
| 68391-400-00 | BERKLEY AND JENSEN ALL DAY ALLERGY | 200 in 1 BOTTLE | TABLET, FILM COATED | 200 | | 2 |
| 68391-400-01 | BERKLEY AND JENSEN ALL DAY ALLERGY | 2 in 1 PACKAGE | TABLET, FILM COATED | 2 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68391-400-00 | 68391040000 | 200 in 1 BOTTLE | | | | | Historical |
| 68391-400-01 | 68391040001 | 2 BOTTLE in 1 PACKAGE (68391-400-01) / 200 TABLET, FILM COATED in 1 BOTTLE (68391-400-00) | 2 bottle | 2025-09-04 | No | No | Current |