Acetaminophen and Codeine Phosphate
- Product NDC
- 64380-447
- 11-digit product format
- 643800447
- Labeler code
- 64380
- Product ID
- 64380-447_c87671eb-3ec7-4930-be25-5686a75679de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetaminophen and Codeine Phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA089828
- Marketing category
- ANDA
- Marketing start
- 2024-05-20
- 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 |
|---|---|
| ACETAMINOPHEN | 300 mg/1 |
| CODEINE PHOSPHATE | 60 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, GSL05Y1MN6 |
| Rxcui | 993770, 993781, 993890 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64380-447-01 | Acetaminophen and Codeine Phosphate | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 64380-447-02 | Acetaminophen and Codeine Phosphate | 500 in 1 BOTTLE | TABLET | 500 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64380-447-01 | EA - Each | 64380-447 | e7602ae3-1214-459a-837c-5ca7bad5658a | 1 | 2024-06-10 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 993770 | codeine phosphate 15 MG / acetaminophen 300 MG Oral Tablet | PSN | c459ed02-afd6-4533-82b6-bfb2c7ab0e72 | 1 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | c459ed02-afd6-4533-82b6-bfb2c7ab0e72 | 1 |
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | 36988ba2-cefd-99f8-e063-6294a90aa41a | 1 |
| 993890 | codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet | PSN | caa96b80-d8a7-4920-9d5c-717435e798de | 1 |
| 993890 | codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet | PSN | 36988ba2-cefd-99f8-e063-6294a90aa41a | 1 |
| 993890 | codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet | PSN | 3e41e55f-7e41-4653-aadb-32a9e47962d9 | 1 |
| 993890 | codeine phosphate 60 MG / acetaminophen 300 MG Oral Tablet | PSN | c459ed02-afd6-4533-82b6-bfb2c7ab0e72 | 1 |
| 993770 | acetaminophen 300 MG / codeine phosphate 15 MG Oral Tablet | SCD | c459ed02-afd6-4533-82b6-bfb2c7ab0e72 | 1 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | 36988ba2-cefd-99f8-e063-6294a90aa41a | 1 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | c459ed02-afd6-4533-82b6-bfb2c7ab0e72 | 1 |
| 993890 | acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet | SCD | caa96b80-d8a7-4920-9d5c-717435e798de | 1 |
| 993890 | acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet | SCD | 3e41e55f-7e41-4653-aadb-32a9e47962d9 | 1 |
| 993890 | acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet | SCD | c459ed02-afd6-4533-82b6-bfb2c7ab0e72 | 1 |
| 993890 | acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet | SCD | 36988ba2-cefd-99f8-e063-6294a90aa41a | 1 |
| 993770 | APAP 300 MG / codeine phosphate 15 MG Oral Tablet | SY | c459ed02-afd6-4533-82b6-bfb2c7ab0e72 | 1 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | 36988ba2-cefd-99f8-e063-6294a90aa41a | 1 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | c459ed02-afd6-4533-82b6-bfb2c7ab0e72 | 1 |
| 993890 | APAP 300 MG / codeine phosphate 60 MG Oral Tablet | SY | caa96b80-d8a7-4920-9d5c-717435e798de | 1 |
| 993890 | APAP 300 MG / codeine phosphate 60 MG Oral Tablet | SY | c459ed02-afd6-4533-82b6-bfb2c7ab0e72 | 1 |
| 993890 | APAP 300 MG / codeine phosphate 60 MG Oral Tablet | SY | 3e41e55f-7e41-4653-aadb-32a9e47962d9 | 1 |
| 993890 | APAP 300 MG / codeine phosphate 60 MG Oral Tablet | SY | 36988ba2-cefd-99f8-e063-6294a90aa41a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 64380-447-01 | 64380044701 | 100 TABLET in 1 BOTTLE (64380-447-01) | 100 tablet | 2024-05-20 | No | No | Current |
| 64380-447-02 | 64380044702 | 500 TABLET in 1 BOTTLE (64380-447-02) | 500 tablet | 2024-05-20 | No | No | Current |