PROMETHAZINE HYDROCHLORIDE
- Product NDC
- 0116-4023
- 11-digit product format
- 001164023
- Labeler code
- 0116
- Product ID
- 0116-4023_302bfe23-7984-140e-e063-6394a90acad1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- promethazine hydrochloride
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Xttrium Laboratories, Inc.
- Application
- ANDA087953
- Marketing category
- ANDA
- Marketing start
- 2025-04-07
- 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 |
|---|
| 0116-4023-16 | PROMETHAZINE HYDROCHLORIDE | 473 mL in 1 BOTTLE, PLASTIC | SYRUP | 473 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0116-4023 | PROMETHAZINE HYDROCHLORIDE SYRUP [XTTRIUM LABORATORIES, INC.] | 1 | Current NDC, 1 package rows | 20250410_302bfea2-d403-d315-e063-6294a90a37dd.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 |
|---|
| 0116-4023-16 | 00116402316 | 473 mL in 1 BOTTLE, PLASTIC (0116-4023-16) | 473 ml | 2025-04-07 | No | No | Historical |