Promethazine Hydrochloride
- Product NDC
- 10135-495
- 11-digit product format
- 101350495
- Labeler code
- 10135
- Product ID
- 10135-495_ecac401c-0a8f-d482-e053-2995a90ad3c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- promethazine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals Inc
- Application
- ANDA091179
- Marketing category
- ANDA
- Marketing start
- 2016-10-01
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-495-01 | Promethazine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 10135-495-10 | Promethazine Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-495 | PROMETHAZINE HYDROCHLORIDE TABLET [MARLEX PHARMACEUTICALS INC] | 8 | Legacy NDC, 2 package rows | 20231123_7834998b-2c53-4edc-97d9-508f7cc92f7c.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 |
|---|
| 10135-495-01 | 10135049501 | 100 TABLET in 1 BOTTLE (10135-495-01) | 100 tablet | 2016-10-01 | 0000-00-00 | No | No | Current |
| 10135-495-10 | 10135049510 | 1000 TABLET in 1 BOTTLE (10135-495-10) | 1000 tablet | 2016-10-01 | 0000-00-00 | No | No | Current |