Promethazine Hydrochloride
- Product NDC
- 0615-8154
- 11-digit product format
- 006158154
- Labeler code
- 0615
- Product ID
- 0615-8154_a5a8489f-e7ef-4f8a-8c6f-fc2c1437c91c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA040596
- Marketing category
- ANDA
- Marketing start
- 2018-07-02
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R61ZEH7I1I |
| Rxcui | 992447 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8154-39 | Promethazine Hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8154 | PROMETHAZINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240918_a4fbc2d8-19b3-4556-b0b9-6e7a14cd4c36.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-8154-39 | 00615815439 | 30 TABLET in 1 BLISTER PACK (0615-8154-39) | 30 tablet | 2018-07-02 | 0000-00-00 | No | No | Current |