Promethazine Hydrochloride
- Product NDC
- 55154-3373
- 11-digit product format
- 551543373
- Labeler code
- 55154
- Product ID
- 55154-3373_6b7956e8-7bdc-4b48-9779-0b655c46e8ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA091179
- Marketing category
- ANDA
- Marketing start
- 2024-07-02
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Promethazine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROMETHAZINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R61ZEH7I1I |
| Rxcui | 992447 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-3373-0 | Promethazine Hydrochloride | 1 in 1 BLISTER PACK | TABLET | 1 | | 2 |
| 55154-3373-0 | Promethazine Hydrochloride | 10 in 1 BAG | TABLET | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-3373 | PROMETHAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH 107, LLC] | 1 | Current NDC, 2 package rows | 20240706_e16238dc-9292-49ac-b80f-8afeccb88bc5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55154-3373-0 | 55154337300 | 10 BLISTER PACK in 1 BAG (55154-3373-0) / 1 TABLET in 1 BLISTER PACK | 10 blister pack | 2024-07-02 | No | No | Historical |