Promethazine Hydrochloride
- Product NDC
- 55154-2861
- 11-digit product format
- 551542861
- Labeler code
- 55154
- Product ID
- 55154-2861_5002c2f5-9a52-44a9-a6a1-5e4bd811b7c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA083312
- Marketing category
- ANDA
- Marketing start
- 1973-09-19
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/mL
- 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 | 25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R61ZEH7I1I |
| Rxcui | 992460 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-2861-5 | Promethazine Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 9 |
| 55154-2861-5 | Promethazine Hydrochloride | 5 in 1 BAG | INJECTION | 5 | | 9 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-2861 | PROMETHAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH 107, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240321_7ce351d8-47be-4937-aad2-153208c93b53.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55154-2861-5 | 55154286105 | 5 VIAL, SINGLE-DOSE in 1 BAG (55154-2861-5) / 1 mL in 1 VIAL, SINGLE-DOSE | 1973-09-19 | 0000-00-00 | No | No | Current |