Acetaminophen
- Product NDC
- 55315-333
- 11-digit product format
- 553150333
- Labeler code
- 55315
- Product ID
- 55315-333_bb89acc6-20df-465f-aca0-424c0d4dc32f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Fred's Inc.
- Application
- ANDA076200
- Marketing category
- ANDA
- Marketing start
- 2004-04-30
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN
- Active strength
- 650 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [FRED'S INC.] | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [FRED'S INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [FRED'S INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [FRED'S INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [FRED'S INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [FRED'S INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [FRED'S INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [FRED'S INC.] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [FRED'S INC.] | 1 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [FRED'S INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [FRED'S INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [FRED'S INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55315-333 | ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [FRED'S INC.] | 2 | Legacy NDC | 20191225_070569ec-82b1-4b26-b38b-3fb3caf71f19.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55315-333-50 | 55315033350 | 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55315-333-50) | 2019-12-24 | 0000-00-00 | No | No | Current |