FAMOTIDINE
- Product NDC
- 68210-0007
- 11-digit product format
- 682100007
- Labeler code
- 68210
- Product ID
- 68210-0007_0935b09d-5609-4cc5-a65c-e5da29bc9449
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- FAMOTIDINE
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- SPIRIT PHARMACEUTICALS,LLC
- Application
- ANDA077146
- Marketing category
- ANDA
- Marketing start
- 2013-08-19
- Marketing end
- 0000-00-00
- Substance
- FAMOTIDINE
- Active strength
- 10 mg/1
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68210-0007-0 | FAMOTIDINE | 6 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 6 | | 1 |
| 68210-0007-0 | FAMOTIDINE | 2 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 2 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FAMOTIDINE | ACTIVE INGREDIENT | 5QZO15J2Z8 | FAMOTIDINE TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] | 1 | |
| FAMOTIDINE | ACTIVE MOIETY | 5QZO15J2Z8 | FAMOTIDINE TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FAMOTIDINE TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | FAMOTIDINE TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | FAMOTIDINE TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FAMOTIDINE TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FAMOTIDINE TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | FAMOTIDINE TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | FAMOTIDINE TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FAMOTIDINE TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | FAMOTIDINE TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68210-0007 | FAMOTIDINE TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC] | 1 | Legacy NDC, 2 package rows | 20130911_84a9a761-7d6f-4e63-814f-e7a71e0ff11b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68210-0007-0 | 68210000700 | 6 in 1 BLISTER PACK | Historical |