Acetaminophen and Codeine Phosphate
- Product NDC
- 33261-470
- 11-digit product format
- 332610470
- Labeler code
- 33261
- Product ID
- 33261-470_86859de8-6f89-477b-8e5a-c9634bb99693
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ACETAMINOPHEN and CODEINE PHOSPHATE
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA087508
- Marketing category
- ANDA
- Marketing start
- 1981-08-21
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 120 mg/5mL; mg/5mL
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|---|---|---|---|---|
| 33261-470-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a32a-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Oral Solution USP CV |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33261-470-01 | Acetaminophen and Codeine Phosphate | 118 mL in 1 BOTTLE, PLASTIC | SOLUTION | 118 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 33261-470-01 | ML - Milliliter | 33261-470 | 8b4e6ac9-3c73-4a04-acfd-c0031a23f423 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 993755 | codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral Solution | PSN | 59c33fd9-ef24-4893-b904-3e5f8cea58c7 | 3 |
| 993755 | acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral Solution | SCD | 59c33fd9-ef24-4893-b904-3e5f8cea58c7 | 3 |
| 993755 | acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral Solution | SY | 59c33fd9-ef24-4893-b904-3e5f8cea58c7 | 3 |
| 993755 | acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral Solution | SY | 59c33fd9-ef24-4893-b904-3e5f8cea58c7 | 3 |
| 993755 | APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral Solution | SY | 59c33fd9-ef24-4893-b904-3e5f8cea58c7 | 3 |
| 993755 | codeine phosphate 12 MG / acetaminophen 120 MG per 5 ML Oral Solution | SY | 59c33fd9-ef24-4893-b904-3e5f8cea58c7 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 33261-470-01 | 33261047001 | 118 mL in 1 BOTTLE, PLASTIC | 118 ml | Historical |