PROMETHAZINE HYDROCHLORIDE
- Product NDC
- 17856-4023
- 11-digit product format
- 178564023
- Labeler code
- 17856
- Product ID
- 17856-4023_4f99bbe0-279d-da57-e063-6294a90ab362
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- promethazine hydrochloride
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Atlantic Biologicals Corp.
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PROMETHAZINE HYDROCHLORIDE
- Listing expiration
- 2027-12-31
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 |
|---|
| 17856-4023-1 | PROMETHAZINE HYDROCHLORIDE | 72 in 1 CASE | SYRUP | 72 | | 1 |
| 17856-4023-1 | PROMETHAZINE HYDROCHLORIDE | 5 mL in 1 CUP, UNIT-DOSE | SYRUP | 5 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 17856-4023-1 | 17856402301 | 72 CUP, UNIT-DOSE in 1 CASE (17856-4023-1) / 5 mL in 1 CUP, UNIT-DOSE | 2026-04-20 | No | No | Historical |