ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 71335-1522
- 11-digit product format
- 713351522
- Labeler code
- 71335
- Product ID
- 71335-1522_71cd2ab2-dbe2-4c8b-904a-c8ad320181f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA040419
- Marketing category
- ANDA
- Marketing start
- 2001-05-31
- 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
openFDA Listing Details
- Product ID
- 71335-1522_71cd2ab2-dbe2-4c8b-904a-c8ad320181f9
- SPL ID
- 71cd2ab2-dbe2-4c8b-904a-c8ad320181f9
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- ACETAMINOPHEN AND CODEINE PHOSPHATE
- Generic name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2001-05-31
- Marketing category
- ANDA
- Application number
- ANDA040419
- Pharmacologic classes
- Full Opioid Agonists [MoA]; Opioid Agonist [EPC]
- DEA schedule
- CIII
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 300 mg/1 |
| CODEINE PHOSPHATE | 30 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 362O9ITL9D, GSL05Y1MN6 |
| Rxcui | 993781 |
| Spl Set Id | 3f7737d1-ec78-467e-8903-9cb8eba0ab0b |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-1522-0 | 40 TABLET in 1 BOTTLE (71335-1522-0) | 2020-08-17 | No |
| 71335-1522-1 | 6 TABLET in 1 BOTTLE (71335-1522-1) | 2020-03-13 | No |
| 71335-1522-2 | 20 TABLET in 1 BOTTLE (71335-1522-2) | 2020-03-30 | No |
| 71335-1522-3 | 30 TABLET in 1 BOTTLE (71335-1522-3) | 2020-03-05 | No |
| 71335-1522-4 | 84 TABLET in 1 BOTTLE (71335-1522-4) | 2024-04-03 | No |
| 71335-1522-5 | 15 TABLET in 1 BOTTLE (71335-1522-5) | 2020-03-06 | No |
| 71335-1522-6 | 120 TABLET in 1 BOTTLE (71335-1522-6) | 2020-03-03 | No |
| 71335-1522-7 | 100 TABLET in 1 BOTTLE (71335-1522-7) | 2024-04-03 | No |
| 71335-1522-8 | 60 TABLET in 1 BOTTLE (71335-1522-8) | 2020-02-24 | No |
| 71335-1522-9 | 90 TABLET in 1 BOTTLE (71335-1522-9) | 2020-03-06 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 362O9ITL9D | ACETAMINOPHEN | 103-90-2 | ACETAMINOPHEN |
| GSL05Y1MN6 | CODEINE PHOSPHATE | 41444-62-6 | CODEINE PHOSPHATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-1522-0 | 71335152200 | 40 TABLET in 1 BOTTLE (71335-1522-0) | 40 tablet | 2020-08-17 | No | No | Historical |
| 71335-1522-1 | 71335152201 | 6 TABLET in 1 BOTTLE (71335-1522-1) | 6 tablet | 2020-03-13 | No | No | Historical |
| 71335-1522-2 | 71335152202 | 20 TABLET in 1 BOTTLE (71335-1522-2) | 20 tablet | 2020-03-30 | No | No | Historical |
| 71335-1522-3 | 71335152203 | 30 TABLET in 1 BOTTLE (71335-1522-3) | 30 tablet | 2020-03-05 | No | No | Historical |
| 71335-1522-4 | 71335152204 | 84 TABLET in 1 BOTTLE (71335-1522-4) | 84 tablet | 2024-04-03 | No | No | Historical |
| 71335-1522-5 | 71335152205 | 15 TABLET in 1 BOTTLE (71335-1522-5) | 15 tablet | 2020-03-06 | No | No | Historical |
| 71335-1522-6 | 71335152206 | 120 TABLET in 1 BOTTLE (71335-1522-6) | 120 tablet | 2020-03-03 | No | No | Historical |
| 71335-1522-7 | 71335152207 | 100 TABLET in 1 BOTTLE (71335-1522-7) | 100 tablet | 2024-04-03 | No | No | Historical |
| 71335-1522-8 | 71335152208 | 60 TABLET in 1 BOTTLE (71335-1522-8) | 60 tablet | 2020-02-24 | No | No | Historical |
| 71335-1522-9 | 71335152209 | 90 TABLET in 1 BOTTLE (71335-1522-9) | 90 tablet | 2020-03-06 | No | No | Historical |