Acetaminophen and Codeine Phosphate
- Product NDC
- 64380-448
- 11-digit product format
- 643800448
- Labeler code
- 64380
- Product ID
- 64380-448_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
- ANDA089990
- Marketing category
- ANDA
- Marketing start
- 2024-05-20
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 300; 15 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64380-448-01 | Acetaminophen and Codeine Phosphate | 100 in 1 BOTTLE | TABLET | 100 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64380-448-01 | EA - Each | 64380-448 | 91e454a4-f5c4-41f4-982c-578e3380cead | 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 |
| 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 | c459ed02-afd6-4533-82b6-bfb2c7ab0e72 | 1 |
| 993890 | acetaminophen 300 MG / codeine phosphate 60 MG Oral Tablet | SCD | c459ed02-afd6-4533-82b6-bfb2c7ab0e72 | 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 | c459ed02-afd6-4533-82b6-bfb2c7ab0e72 | 1 |
| 993890 | APAP 300 MG / codeine phosphate 60 MG Oral Tablet | SY | c459ed02-afd6-4533-82b6-bfb2c7ab0e72 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 64380-448-01 | 64380044801 | 100 TABLET in 1 BOTTLE (64380-448-01) | 100 tablet | 2024-05-20 | No | No | Historical |