Cimetidine Hydrochloride Oral Solution
- Product NDC
- 50383-050
- 11-digit product format
- 503830050
- Labeler code
- 50383
- Product ID
- 50383-050_283fc6ae-681a-419b-b155-dab73acf4403
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cimetidine Hydrochloride Oral Solution
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Akorn Operating Company LLC
- Application
- ANDA074664
- Marketing category
- ANDA
- Marketing start
- 1997-10-28
- Marketing end
- 0000-00-00
- Substance
- CIMETIDINE HYDROCHLORIDE
- Active strength
- 300 mg/5mL
- Pharmacologic classes
- Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
- 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 |
|---|
| 50383-050-08 | Cimetidine Hydrochloride Oral Solution | 237 mL in 1 BOTTLE | SOLUTION | 237 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CIMETIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | WF10491673 | CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] | 1 | |
| CIMETIDINE | ACTIVE MOIETY | 80061L1WGD | CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] | 1 | |
| ORANGE | INACTIVE INGREDIENT | 5EVU04N5QU | CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] | 1 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] | 1 | |
| SODIUM PHOSPHATE, DIBASIC ANHYDROUS | INACTIVE INGREDIENT | 22ADO53M6F | CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [HI-TECH PHARMACAL CO., INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50383-050 | CIMETIDINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [AKORN OPERATING COMPANY LLC] | 4 | Legacy NDC, 1 package rows | 20221018_f2ec923a-2b88-43c0-ac2a-7ae20c053039.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 |
|---|
| 50383-050-08 | 50383005008 | 237 mL in 1 BOTTLE (50383-050-08) | 237 ml | 1997-10-28 | 0000-00-00 | No | No | Current |