Acetaminophen and Codeine Phosphate
- Product NDC
- 13107-060
- 11-digit product format
- 131070060
- Labeler code
- 13107
- Product ID
- 13107-060_d0765823-c018-4aae-85e9-27288fe43950
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetaminophen and Codeine Phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurolife Pharma, LLC
- Application
- ANDA202800
- Marketing category
- ANDA
- Marketing start
- 2013-04-15
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 300; 60 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acetaminophen and Codeine Phosphate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 300 mg/1 |
| CODEINE PHOSPHATE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | GSL05Y1MN6, 362O9ITL9D |
| Rxcui | 993770, 993781, 993890 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13107-060-01 | Acetaminophen and Codeine Phosphate | 100 in 1 BOTTLE | TABLET | 100 | | 23 |
| 13107-060-05 | Acetaminophen and Codeine Phosphate | 500 in 1 BOTTLE | TABLET | 500 | | 23 |
| 13107-060-30 | Acetaminophen and Codeine Phosphate | 30 in 1 BOTTLE | TABLET | 30 | | 23 |
| 13107-060-99 | Acetaminophen and Codeine Phosphate | 1000 in 1 BOTTLE | TABLET | 1000 | | 23 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC] | 4 | |
| CODEINE PHOSPHATE | ACTIVE INGREDIENT | GSL05Y1MN6 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC] | 4 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC] | 4 | |
| CODEINE ANHYDROUS | ACTIVE MOIETY | UX6OWY2V7J | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC] | 4 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC] | 4 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC] | 4 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC] | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC] | 4 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13107-060 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [AUROLIFE PHARMA, LLC] | 21 | Current NDC, Legacy NDC, 4 package rows | 20240726_02386806-02d4-47e3-9c8b-7810146ee795.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 |
|---|
| 13107-060-01 | 13107006001 | 100 TABLET in 1 BOTTLE (13107-060-01) | 100 tablet | 2013-04-15 | 0000-00-00 | No | No | Current |
| 13107-060-05 | 13107006005 | 500 TABLET in 1 BOTTLE (13107-060-05) | 500 tablet | 2013-04-15 | 0000-00-00 | No | No | Current |
| 13107-060-30 | 13107006030 | 30 TABLET in 1 BOTTLE (13107-060-30) | 30 tablet | 2013-04-15 | 0000-00-00 | No | No | Current |
| 13107-060-99 | 13107006099 | 1000 TABLET in 1 BOTTLE (13107-060-99) | 1000 tablet | 2013-04-15 | 0000-00-00 | No | No | Current |