Promethazine Hydrochloride
- Product NDC
- 58118-5307
- 11-digit product format
- 581185307
- Labeler code
- 58118
- Product ID
- 58118-5307_ab5ca106-f199-a42c-e053-2a95a90a1e24
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Clinical Solutions Wholesale
- Application
- ANDA083426
- Marketing category
- ANDA
- Marketing start
- 1973-09-19
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58118-5307-0 | 2024-01-30 | C162847 | 48780-1 | 1030e365-245e-111a-e063-dadaa90a10e2 | 17f72b60-87e8-4d1e-b3f5-2f8a944f5478 |
| 58118-5307-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-245e-111a-e063-dadaa90a10e2 | 17f72b60-87e8-4d1e-b3f5-2f8a944f5478 |
| 58118-5307-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-245e-111a-e063-dadaa90a10e2 | 17f72b60-87e8-4d1e-b3f5-2f8a944f5478 |
| 58118-5307-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-245e-111a-e063-dadaa90a10e2 | 17f72b60-87e8-4d1e-b3f5-2f8a944f5478 |
| 58118-5307-8 | 2024-01-30 | C162847 | 48780-1 | 1030e365-245e-111a-e063-dadaa90a10e2 | 17f72b60-87e8-4d1e-b3f5-2f8a944f5478 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHAZINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE] | 1 | |
| PROMETHAZINE | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PROMETHAZINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE] | 1 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | PROMETHAZINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PROMETHAZINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PROMETHAZINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | PROMETHAZINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58118-5307 | PROMETHAZINE HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE] | 8 | Legacy NDC | 20200727_17f72b60-87e8-4d1e-b3f5-2f8a944f5478.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58118-5307-8 | 58118530708 | 30 TABLET in 1 BLISTER PACK (58118-5307-8) | 30 tablet | 1973-09-19 | 0000-00-00 | No | No | Current |