Promethazine Hydrochloride
- Product NDC
- 0404-9941
- 11-digit product format
- 004049941
- Labeler code
- 0404
- Product ID
- 0404-9941_64108fe9-f7f8-44f8-ab3a-7714a8917ea2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA083312
- Marketing category
- ANDA
- Marketing start
- 2022-01-17
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/mL
- 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/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 |
|---|
| 0404-9941-01 | Promethazine Hydrochloride | 1 mL in 1 AMPULE | INJECTION | 1 | | 6 |
| 0404-9941-01 | Promethazine Hydrochloride | 1 in 1 BAG | INJECTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9941 | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE) INJECTION [HENRY SCHEIN, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241018_d7675718-0a57-41ff-a771-79afc12150aa.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 |
|---|
| 0404-9941-01 | 00404994101 | 1 AMPULE in 1 BAG (0404-9941-01) / 1 mL in 1 AMPULE | 1 ampule | 2022-01-17 | 0000-00-00 | No | No | Current |