Acetaminophen and Codeine
- Product NDC
- 63187-491
- 11-digit product format
- 631870491
- Labeler code
- 63187
- Product ID
- 63187-491_a4e384a6-1887-4053-8263-54fc51823174
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetaminophen and Codeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA040779
- Marketing category
- ANDA
- Marketing start
- 2008-05-29
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 300; 30 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 300 mg/1 |
| CODEINE PHOSPHATE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, GSL05Y1MN6 |
| Rxcui | 993781 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-491-20 | Acetaminophen and Codeine | 20 in 1 BOTTLE | TABLET | 20 | | 4 |
| 63187-491-30 | Acetaminophen and Codeine | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 63187-491-60 | Acetaminophen and Codeine | 60 in 1 BOTTLE | TABLET | 60 | | 4 |
| 63187-491-90 | Acetaminophen and Codeine | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-491 | ACETAMINOPHEN AND CODEINE TABLET [PROFICIENT RX LP] | 4 | Current NDC, Legacy NDC, 4 package rows | 20210114_2472bb8a-88b7-4eec-8806-34adef0c9ab9.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 |
|---|
| 63187-491-20 | 63187049120 | 20 TABLET in 1 BOTTLE (63187-491-20) | 20 tablet | 2015-02-02 | 0000-00-00 | No | No | Current |
| 63187-491-30 | 63187049130 | 30 TABLET in 1 BOTTLE (63187-491-30) | 30 tablet | 2015-02-02 | 0000-00-00 | No | No | Current |
| 63187-491-60 | 63187049160 | 60 TABLET in 1 BOTTLE (63187-491-60) | 60 tablet | 2015-02-02 | 0000-00-00 | No | No | Current |
| 63187-491-90 | 63187049190 | 90 TABLET in 1 BOTTLE (63187-491-90) | 90 tablet | 2015-02-02 | 0000-00-00 | No | No | Current |