Acetaminophen and Codeine
- Product NDC
- 76420-103
- 11-digit product format
- 764200103
- Labeler code
- 76420
- Product ID
- 76420-103_b2dde53b-af58-ce44-e053-2a95a90a8fe0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetaminophen and Codeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- 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 |
|---|
| 76420-103-03 | Acetaminophen and Codeine | 3 in 1 BOTTLE | TABLET | 3 | | 1 |
| 76420-103-10 | Acetaminophen and Codeine | 10 in 1 BOTTLE | TABLET | 10 | | 1 |
| 76420-103-20 | Acetaminophen and Codeine | 20 in 1 BOTTLE | TABLET | 20 | | 1 |
| 76420-103-30 | Acetaminophen and Codeine | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-103 | ACETAMINOPHEN AND CODEINE TABLET [ASCLEMED USA, INC.] | 1 | Current NDC, Legacy NDC, 4 package rows | 20201104_3f83ba75-9415-4ace-9416-04d666c005a2.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 |
|---|
| 76420-103-03 | 76420010303 | 3 TABLET in 1 BOTTLE (76420-103-03) | 3 tablet | 2020-10-30 | 0000-00-00 | No | No | Current |
| 76420-103-10 | 76420010310 | 10 TABLET in 1 BOTTLE (76420-103-10) | 10 tablet | 2020-10-30 | 0000-00-00 | No | No | Current |
| 76420-103-20 | 76420010320 | 20 TABLET in 1 BOTTLE (76420-103-20) | 20 tablet | 2020-10-30 | 0000-00-00 | No | No | Current |
| 76420-103-30 | 76420010330 | 30 TABLET in 1 BOTTLE (76420-103-30) | 30 tablet | 2020-10-30 | 0000-00-00 | No | No | Current |