Promethazine Hydrochloride
- Product NDC
- 0440-5195
- 11-digit product format
- 004405195
- Labeler code
- 0440
- Product ID
- 0440-5195_080af3ed-50a9-4216-9c16-66fc9280a330
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Liberty Pharmaceuticals, Inc.
- Application
- ANDA091179
- Marketing category
- ANDA
- Marketing start
- 2011-03-03
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Phenothiazine [EPC],Phenothiazines [CS]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 |
|---|
| 0440-5195-06 | Promethazine Hydrochloride | 6 in 1 BOTTLE | TABLET | 6 | | 3 |
| 0440-5195-10 | Promethazine Hydrochloride | 10 in 1 BOTTLE | TABLET | 10 | | 3 |
| 0440-5195-12 | Promethazine Hydrochloride | 12 in 1 BOTTLE | TABLET | 12 | | 3 |
| 0440-5195-20 | Promethazine Hydrochloride | 20 in 1 BOTTLE | TABLET | 20 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0440-5195 | PROMETHAZINE HYDROCHLORIDE TABLET [LIBERTY PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 4 package rows | 20171226_c1993112-1eeb-4b24-ac85-e623fdef3dce.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 0440-5195-06 | 00440519506 | 6 in 1 BOTTLE | Historical |
| 0440-5195-10 | 00440519510 | 10 in 1 BOTTLE | Historical |
| 0440-5195-12 | 00440519512 | 12 in 1 BOTTLE | Historical |
| 0440-5195-20 | 00440519520 | 20 in 1 BOTTLE | Historical |