CIMETIDINE
- Product NDC
- 59651-825
- 11-digit product format
- 596510825
- Labeler code
- 59651
- Product ID
- 59651-825_ebd53065-c080-4045-a398-64d3f3b1460f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CIMETIDINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA218997
- Marketing category
- ANDA
- Marketing start
- 2024-11-12
- Substance
- CIMETIDINE
- Active strength
- 400 mg/1
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CIMETIDINE | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 80061L1WGD |
| Rxcui | 197505, 197506, 197507, 197508 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-825-01 | CIMETIDINE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 59651-825-05 | CIMETIDINE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-825 | CIMETIDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | Current NDC, 2 package rows | 20241122_ebd53065-c080-4045-a398-64d3f3b1460f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-825-01 | 59651082501 | 100 TABLET, FILM COATED in 1 BOTTLE (59651-825-01) | 2024-11-12 | No | No | Current |
| 59651-825-05 | 59651082505 | 500 TABLET, FILM COATED in 1 BOTTLE (59651-825-05) | 2024-11-12 | No | No | Current |
| 59651-825-62 | 59651082562 | 30000 TABLET, FILM COATED in 1 BAG (59651-825-62) | 12-NOV-24 | | | Current |