Famotidine
- Product NDC
- 43386-500
- 11-digit product format
- 433860500
- Labeler code
- 43386
- Product ID
- 43386-500_82462011-668a-4fbd-9653-48049901eacc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Famotidine
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA201695
- Marketing category
- ANDA
- Marketing start
- 2012-12-17
- Substance
- FAMOTIDINE
- Active strength
- 40 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
- Famotidine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FAMOTIDINE | 40 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5QZO15J2Z8 |
| Rxcui | 310274 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-500-11 | Famotidine | 50 mL in 1 BOTTLE | FOR SUSPENSION | 50 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FAMOTIDINE | ACTIVE INGREDIENT | 5QZO15J2Z8 | FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| FAMOTIDINE | ACTIVE MOIETY | 5QZO15J2Z8 | FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| METHYLPARABEN SODIUM | INACTIVE INGREDIENT | CR6K9C2NHK | FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | FAMOTIDINE FOR SUSPENSION [GAVIS PHARMACEUTICALS, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-500 | FAMOTIDINE FOR SUSPENSION [LUPIN PHARMACEUTICALS,INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20171122_a0bdf4d1-8458-4e4f-95aa-bcc38c0f32f8.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 |
|---|
| 43386-500-11 | 43386050011 | 50 mL in 1 BOTTLE (43386-500-11) | 50 ml | 2012-12-17 | 0000-00-00 | No | No | Current |