Cimetidine Hydrochloride
- Product NDC
- 0121-1025
- 11-digit product format
- 001211025
- Labeler code
- 0121
- Product ID
- 0121-1025_55abdac4-2b7c-4163-bf5f-d2e934108ba6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cimetidine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA074664
- Marketing category
- ANDA
- Marketing start
- 2025-01-09
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cimetidine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CIMETIDINE HYDROCHLORIDE | 300 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WF10491673 |
| Rxcui | 212787 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-1025-08 | Cimetidine Hydrochloride | 237 mL in 1 BOTTLE | SOLUTION | 237 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-1025 | CIMETIDINE HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 5 | Current NDC, 1 package rows | 20250110_b8b50bd9-bc1b-4da5-96c5-8eb917c8937f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0121-1025-08 | 00121102508 | 237 mL in 1 BOTTLE (0121-1025-08) | 237 ml | 2025-01-09 | No | No | Current |