Acetaminophen and Codeine
- Product NDC
- 50436-3227
- 11-digit product format
- 504363227
- Labeler code
- 50436
- Product ID
- 50436-3227_850264fa-bc78-43d1-85da-187a3cbac55b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetaminophen and Codeine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA040779
- Marketing category
- ANDA
- Marketing start
- 2008-05-29
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 300 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 41b814f3-0166-1c53-c9ef-a0794c7daf9d | Product name | 3 | 20221110 |
| a590be26-846c-8659-a5a1-fb25907965dc | Product name | 2 | 20221110 |
| 09d8330d-4fec-be98-3a66-f985140646b2 | Product name | 2 | 20210513 |
| 20c8cafe-5cfc-44f8-a9be-a664f437f780 | Product name | 2 | 20200225 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
| e9576821-a971-5261-628e-82ad9e10acdb | Product name | 2 | 20150121 |
| 2a21311a-89e2-0e83-2ebd-117f9798b2b2 | Product name | 1 | 20140508 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 47fd879b-91c5-e1e5-130f-29d082a871ec | Product name | 1 | 20140508 |
| c35d1ac8-8885-2ee1-6c52-5a715b242c00 | Product name | 1 | 20140508 |
| ce055423-1d7f-3c41-dff1-83660fa8cd96 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-3227-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2c7f-a910-e053-dadaa90a0b85 | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx only |
| 50436-3227-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2c7f-a910-e053-dadaa90a0b85 | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx only |
| 50436-3227-7 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2c7f-a910-e053-dadaa90a0b85 | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx only |
| 50436-3227-9 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2c7f-a910-e053-dadaa90a0b85 | Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-3227-1 | Acetaminophen and Codeine | 10 in 1 BOTTLE | TABLET | 10 | 13 | |
| 50436-3227-2 | Acetaminophen and Codeine | 20 in 1 BOTTLE | TABLET | 20 | 13 | |
| 50436-3227-7 | Acetaminophen and Codeine | 60 in 1 BOTTLE | TABLET | 60 | 13 | |
| 50436-3227-9 | Acetaminophen and Codeine | 12 in 1 BOTTLE | TABLET | 12 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-3227-7 | EA - Each | 50436-3227 | 89311968-2551-44d9-8458-fde13ecb60a5 | 1 | 2016-05-16 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-3227 | ACETAMINOPHEN AND CODEINE TABLET [UNIT DOSE SERVICES] | 13 | Legacy NDC, 4 package rows | 20170615_c8284691-86f6-4ce0-b680-addc29b35fa6.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | c8284691-86f6-4ce0-b680-addc29b35fa6 | 13 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | c8284691-86f6-4ce0-b680-addc29b35fa6 | 13 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | c8284691-86f6-4ce0-b680-addc29b35fa6 | 13 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-3227-1 | 50436322701 | 10 in 1 BOTTLE | Historical |
| 50436-3227-2 | 50436322702 | 20 in 1 BOTTLE | Historical |
| 50436-3227-7 | 50436322707 | 60 in 1 BOTTLE | Historical |
| 50436-3227-9 | 50436322709 | 12 in 1 BOTTLE | Historical |