Promethazine Hydrochloride
- Product NDC
- 71205-805
- 11-digit product format
- 712050805
- Labeler code
- 71205
- Product ID
- 71205-805_dcb1694a-8451-403c-b848-edb89ba17020
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA040596
- Marketing category
- ANDA
- Marketing start
- 2005-12-14
- 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 |
|---|
| 71205-805-15 | Promethazine Hydrochloride | 15 in 1 BOTTLE | TABLET | 15 | | 1 |
| 71205-805-30 | Promethazine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 71205-805-60 | Promethazine Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 71205-805-90 | Promethazine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-805 | PROMETHAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP] | 1 | Current NDC, 4 package rows | 20230528_dcb1694a-8451-403c-b848-edb89ba17020.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 |
|---|
| 71205-805-15 | 71205080515 | 15 TABLET in 1 BOTTLE (71205-805-15) | 15 tablet | 2023-05-23 | No | No | Current |
| 71205-805-30 | 71205080530 | 30 TABLET in 1 BOTTLE (71205-805-30) | 30 tablet | 2023-05-23 | No | No | Current |
| 71205-805-60 | 71205080560 | 60 TABLET in 1 BOTTLE (71205-805-60) | 60 tablet | 2023-05-23 | No | No | Current |
| 71205-805-90 | 71205080590 | 90 TABLET in 1 BOTTLE (71205-805-90) | 90 tablet | 2023-05-23 | No | No | Current |