Promethazine Hydrochloride
- Product NDC
- 43063-060
- 11-digit product format
- 430630060
- Labeler code
- 43063
- Product ID
- 43063-060_41372747-70d1-1b51-e063-6294a90aef1f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA040500
- Marketing category
- ANDA
- Marketing start
- 2006-05-17
- 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 | 992454 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-060-02 | Promethazine Hydrochloride | 2 in 1 BOTTLE, PLASTIC | SUPPOSITORY | 2 | | 18 |
| 43063-060-04 | Promethazine Hydrochloride | 4 in 1 BOTTLE, PLASTIC | SUPPOSITORY | 4 | | 18 |
| 43063-060-06 | Promethazine Hydrochloride | 6 in 1 BOTTLE, PLASTIC | SUPPOSITORY | 6 | | 18 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-060 | PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.] | 17 | Current NDC, Legacy NDC, 3 package rows | 20241012_7d766cf7-a21c-4eaf-bbdc-00f2939ef19a.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 |
|---|
| 43063-060-02 | 43063006002 | 2 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-060-02) | 2 suppository | 2011-03-28 | 0000-00-00 | No | No | Current |
| 43063-060-04 | 43063006004 | 4 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-060-04) | 4 suppository | 2011-03-28 | 0000-00-00 | No | No | Current |
| 43063-060-06 | 43063006006 | 6 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-060-06) | 6 suppository | 2011-03-28 | 0000-00-00 | No | No | Current |