Promethazine Hydrochloride
- Product NDC
- 0121-1854
- 11-digit product format
- 001211854
- Labeler code
- 0121
- Product ID
- 0121-1854_628c0c05-9610-4a8e-ae9b-f6aad47993d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA040643
- Marketing category
- ANDA
- Marketing start
- 2025-08-07
- 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 |
|---|
| 0121-1854-16 | Promethazine Hydrochloride | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 11 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0121-1854-16 | 00121185416 | 473 mL in 1 BOTTLE (0121-1854-16) | 473 ml | 2025-08-07 | No | No | Historical |