Promethazine Hydrochloride
- Product NDC
- 72162-2071
- 11-digit product format
- 721622071
- Labeler code
- 72162
- Product ID
- 72162-2071_f04e3aa5-37d8-4ba8-919f-9c61255b5bc4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA213890
- Marketing category
- ANDA
- Marketing start
- 2021-07-12
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 6.25 mg/5mL
- 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 | 6.25 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R61ZEH7I1I |
| Rxcui | 992432 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72162-2071-2 | Promethazine Hydrochloride | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 101 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72162-2071 | PROMETHAZINE HYDROCHLORIDE SOLUTION [BRYANT RANCH PREPACK] | 101 | Current NDC, 1 package rows | 20240816_07914b6e-c40f-44be-a1db-8724c70f99b6.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 |
|---|
| 72162-2071-2 | 72162207102 | 473 mL in 1 BOTTLE (72162-2071-2) | 473 ml | 2023-08-15 | No | No | Historical |