Heartburn Relief
- Product NDC
- 83059-0005
- 11-digit product format
- 830590005
- Labeler code
- 83059
- Product ID
- 83059-0005_458b9ea6-72d7-b5af-e063-6294a90a4430
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Shield Pharmaceuticals Corp
- Application
- ANDA215822
- Marketing category
- ANDA
- Marketing start
- 2024-01-16
- Substance
- FAMOTIDINE
- Active strength
- 10 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
- Heartburn Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FAMOTIDINE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5QZO15J2Z8 |
| Rxcui | 199047 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83059-0005-5 | Heartburn Relief | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 6 |
| 83059-0005-5 | Heartburn Relief | 1 in 1 PACKAGE | TABLET, FILM COATED | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83059-0005 | HEARTBURN RELIEF (FAMOTIDINE) TABLET, FILM COATED [SHIELD PHARMACEUTICALS CORP] | 4 | Current NDC, 2 package rows | 20241228_4e02a443-1e4c-46a5-8323-03d749b8634a.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 |
|---|
| 83059-0005-5 | 83059000505 | 1 BOTTLE in 1 PACKAGE (83059-0005-5) / 50 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-01-16 | No | No | Current |