PROMETHAZINE HYDROCHLORIDE
- Product NDC
- 29033-500
- 11-digit product format
- 290330500
- Labeler code
- 29033
- Product ID
- 29033-500_de4790d2-95c1-46e1-b8c6-f5bc14abcdbb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PROMETHAZINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Nostrum Laboratories, Inc.
- Application
- ANDA040891
- Marketing category
- ANDA
- Marketing start
- 2024-07-18
- 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 |
|---|
| 29033-500-34 | PROMETHAZINE HYDROCHLORIDE | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29033-500 | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE) SOLUTION [NOSTRUM LABORATORIES, INC.] | 4 | Current NDC, 1 package rows | 20250315_248cfe2a-deb1-4d7d-9f7f-15babee864bb.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 |
|---|
| 29033-500-34 | 29033050034 | 473 mL in 1 BOTTLE (29033-500-34) | 473 ml | 2024-07-18 | No | No | Historical |