Acetaminophen and Codeine Phosphate
- Product NDC
- 64850-641
- 11-digit product format
- 648500641
- Labeler code
- 64850
- Product ID
- 64850-641_d61159a3-cb34-4931-8185-e1eb41654a8a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetaminophen and Codeine Phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Elite Laboratories, Inc.
- Application
- ANDA212418
- Marketing category
- ANDA
- Marketing start
- 2019-09-10
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acetaminophen and Codeine Phosphate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 300 mg/1 |
| CODEINE PHOSPHATE | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, GSL05Y1MN6 |
| Rxcui | 993770, 993781, 993890 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64850-641-01 | Acetaminophen and Codeine Phosphate | 100 in 1 BOTTLE | TABLET | 100 | | 17 |
| 64850-641-05 | Acetaminophen and Codeine Phosphate | 500 in 1 BOTTLE | TABLET | 500 | | 17 |
| 64850-641-12 | Acetaminophen and Codeine Phosphate | 120 in 1 BOTTLE | TABLET | 120 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64850-641 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [ELITE LABORATORIES, INC.] | 14 | Current NDC, Legacy NDC, 3 package rows | 20250417_6286e128-1288-4dc0-b14b-f04a0e2a22f9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64850-641-01 | 64850064101 | 100 TABLET in 1 BOTTLE (64850-641-01) | 100 tablet | 2024-05-03 | | No | No | Historical |
| 64850-641-05 | 64850064105 | 500 TABLET in 1 BOTTLE (64850-641-05) | 500 tablet | 2025-02-10 | | No | No | Historical |
| 64850-641-12 | 64850064112 | 120 TABLET in 1 BOTTLE (64850-641-12) | 120 tablet | 2019-09-10 | 0000-00-00 | No | No | Current |