ACETAMINOPHEN with CODEINE
- Product NDC
- 54348-015
- 11-digit product format
- 543480015
- Labeler code
- 54348
- Product ID
- 54348-015_ab7b039f-49a0-4c2b-b1ad-b14e89448cc8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ACETAMINOPHEN, CODEINE PHOSPHATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PharmPak, Inc.
- Application
- ANDA089805
- Marketing category
- ANDA
- Marketing start
- 2013-12-31
- Marketing end
- 0000-00-00
- Substance
- CODEINE PHOSPHATE; ACETAMINOPHEN
- Active strength
- 30 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIII
- 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 |
|---|
| 54348-015-01 | ACETAMINOPHEN with CODEINE | 1 in 1 BOX | TABLET | 1 | | 1 |
| 54348-015-01 | ACETAMINOPHEN with CODEINE | 1 in 1 BLISTER PACK | TABLET | 1 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | ACETAMINOPHEN WITH CODEINE (ACETAMINOPHEN, CODEINE PHOSPHATE) TABLET [PHARMPAK, INC.] | 1 | |
| CODEINE PHOSPHATE | ACTIVE INGREDIENT | GSL05Y1MN6 | ACETAMINOPHEN WITH CODEINE (ACETAMINOPHEN, CODEINE PHOSPHATE) TABLET [PHARMPAK, INC.] | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | ACETAMINOPHEN WITH CODEINE (ACETAMINOPHEN, CODEINE PHOSPHATE) TABLET [PHARMPAK, INC.] | 1 | |
| CODEINE ANHYDROUS | ACTIVE MOIETY | UX6OWY2V7J | ACETAMINOPHEN WITH CODEINE (ACETAMINOPHEN, CODEINE PHOSPHATE) TABLET [PHARMPAK, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ACETAMINOPHEN WITH CODEINE (ACETAMINOPHEN, CODEINE PHOSPHATE) TABLET [PHARMPAK, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ACETAMINOPHEN WITH CODEINE (ACETAMINOPHEN, CODEINE PHOSPHATE) TABLET [PHARMPAK, INC.] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | ACETAMINOPHEN WITH CODEINE (ACETAMINOPHEN, CODEINE PHOSPHATE) TABLET [PHARMPAK, INC.] | 1 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | ACETAMINOPHEN WITH CODEINE (ACETAMINOPHEN, CODEINE PHOSPHATE) TABLET [PHARMPAK, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ACETAMINOPHEN WITH CODEINE (ACETAMINOPHEN, CODEINE PHOSPHATE) TABLET [PHARMPAK, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ACETAMINOPHEN WITH CODEINE (ACETAMINOPHEN, CODEINE PHOSPHATE) TABLET [PHARMPAK, INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | ACETAMINOPHEN WITH CODEINE (ACETAMINOPHEN, CODEINE PHOSPHATE) TABLET [PHARMPAK, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54348-015 | ACETAMINOPHEN WITH CODEINE (ACETAMINOPHEN, CODEINE PHOSPHATE) TABLET [PHARMPAK, INC.] | 1 | Legacy NDC, 2 package rows | 20150116_36adb32c-638c-4d6e-b66a-1a1c35174ce6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 54348-015-01 | 54348001501 | 1 in 1 BOX | Historical |