Chlorpromazine hydrochloride
- Product NDC
- 68083-533
- 11-digit product format
- 680830533
- Labeler code
- 68083
- Product ID
- 68083-533_ffd998aa-4c6f-4463-b77c-9dc2e722b948
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Chlorpromazine hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Gland Pharma Limited
- Application
- ANDA216911
- Marketing category
- ANDA
- Marketing start
- 2024-10-04
- Substance
- CHLORPROMAZINE 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
- Chlorpromazine hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHLORPROMAZINE HYDROCHLORIDE | 25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9WP59609J6 |
| Rxcui | 1730076, 1730078 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-533-25 | Chlorpromazine hydrochloride | 25 in 1 CARTON | INJECTION | 25 | | 3 |
| 68083-533-25 | Chlorpromazine hydrochloride | 1 mL in 1 VIAL | INJECTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-533 | CHLORPROMAZINE HYDROCHLORIDE INJECTION [GLAND PHARMA LIMITED] | 3 | Current NDC, 2 package rows | 20241012_867d5c7f-52d4-4794-b1d4-6747f3262fba.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-533-25 | 68083053325 | 25 VIAL in 1 CARTON (68083-533-25) / 1 mL in 1 VIAL | 25 vial | 2024-10-04 | No | No | Current |