Pepcid Complete
- Product NDC
- 53209-4001
- 11-digit product format
- 532094001
- Labeler code
- 53209
- Product ID
- 53209-4001_37e8dec7-0fdb-a2b0-e063-6394a90abfc8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Famotidine, Calcium carbonate, and Magnesium hydroxide
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Morning Star OTC
- Application
- NDA020958
- Marketing category
- NDA
- Marketing start
- 2025-06-19
- Substance
- CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
- Active strength
- 800; 10; 165 mg/1; mg/1; 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
- Pepcid Complete
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CALCIUM CARBONATE | 800 mg/1 |
| FAMOTIDINE | 10 mg/1 |
| MAGNESIUM HYDROXIDE | 165 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H0G9379FGK, 5QZO15J2Z8, NBZ3QY004S |
| Rxcui | 283641, 688892 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53209-4001-1 | Pepcid Complete | 1 in 1 BLISTER PACK | TABLET, CHEWABLE | 1 | | 1 |
| 53209-4001-2 | Pepcid Complete | 25 in 1 PACKET | TABLET, CHEWABLE | 25 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 53209-4001-1 | 53209400101 | 1 in 1 BLISTER PACK | | | | | Historical |
| 53209-4001-2 | 53209400102 | 25 BLISTER PACK in 1 PACKET (53209-4001-2) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (53209-4001-1) | 25 blister pack | 2025-06-19 | No | No | Historical |