Promethazine Hydrochloride
- Product NDC
- 68084-155
- 11-digit product format
- 680840155
- Labeler code
- 68084
- Product ID
- 68084-155_437dac5e-3b6a-4c85-e063-6394a90a0d43
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA040596
- Marketing category
- ANDA
- Marketing start
- 2006-08-30
- 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 |
|---|
| 68084-155-01 | Promethazine Hydrochloride | 100 in 1 CARTON | TABLET | 100 | | 10 |
| 68084-155-11 | Promethazine Hydrochloride | 1 in 1 BLISTER PACK | TABLET | 1 | | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-155 | PROMETHAZINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240415_a8fe4bc5-961b-4441-b8e2-ef93e4e137b6.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 |
|---|
| 68084-155-01 | 68084015501 | 100 BLISTER PACK in 1 CARTON (68084-155-01) / 1 TABLET in 1 BLISTER PACK (68084-155-11) | 100 blister pack | 2006-08-30 | 0000-00-00 | No | No | Current |
| 68084-155-11 | 68084015511 | 1 in 1 BLISTER PACK | | | | | | Historical |