Promethazine Hydrochloride
- Product NDC
- 31722-040
- 11-digit product format
- 317220040
- Labeler code
- 31722
- Product ID
- 31722-040_ecb3a4da-a4fc-7803-e053-2a95a90a0f3f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA216446
- Marketing category
- ANDA
- Marketing start
- 2022-11-02
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 12.5 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 | 12.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R61ZEH7I1I |
| Rxcui | 992441, 992454 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-040-31 | Promethazine Hydrochloride | 6 in 1 BLISTER PACK | SUPPOSITORY | 6 | | 1 |
| 31722-040-31 | Promethazine Hydrochloride | 2 in 1 CARTON | SUPPOSITORY | 2 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-040 | PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20221105_ba7d9e82-9b13-4607-b2f9-25e575b8c73b.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 |
|---|
| 31722-040-31 | 31722004031 | 2 BLISTER PACK in 1 CARTON (31722-040-31) / 6 SUPPOSITORY in 1 BLISTER PACK | 2 blister pack | 2022-11-02 | 0000-00-00 | No | No | Current |