ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 67544-003
- 11-digit product format
- 675440003
- Labeler code
- 67544
- Product ID
- 67544-003_c4cf2f28-c73e-4370-843e-487b7b42e077
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA040419
- Marketing category
- ANDA
- Marketing start
- 2011-07-06
- 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 |
|---|
| 67544-003-53 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 5 |
| 67544-003-60 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 5 |
| 67544-003-70 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | | 5 |
| 67544-003-80 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 180 in 1 BOTTLE, PLASTIC | TABLET | 180 | | 5 |
| 67544-003-90 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 240 in 1 BOTTLE, PLASTIC | TABLET | 240 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67544-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 5 | Current NDC, Legacy NDC, 5 package rows | 20250110_d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1.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 |
|---|
| 67544-003-53 | 67544000353 | 60 TABLET in 1 BOTTLE, PLASTIC (67544-003-53) | 60 tablet | 2011-07-06 | 0000-00-00 | No | No | Current |
| 67544-003-60 | 67544000360 | 90 TABLET in 1 BOTTLE, PLASTIC (67544-003-60) | 90 tablet | 2011-07-06 | 0000-00-00 | No | No | Current |
| 67544-003-70 | 67544000370 | 120 TABLET in 1 BOTTLE, PLASTIC (67544-003-70) | 120 tablet | 2011-07-06 | 0000-00-00 | No | No | Current |
| 67544-003-80 | 67544000380 | 180 TABLET in 1 BOTTLE, PLASTIC (67544-003-80) | 180 tablet | 2011-07-06 | 0000-00-00 | No | No | Current |
| 67544-003-90 | 67544000390 | 240 TABLET in 1 BOTTLE, PLASTIC (67544-003-90) | 240 tablet | 2011-07-06 | 0000-00-00 | No | No | Current |