ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 12634-526
- 11-digit product format
- 126340526
- Labeler code
- 12634
- Product ID
- 12634-526_29b3e671-afb3-2c71-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ACETAMINOPHEN AND CODEINE PHOSPHATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotheca, Inc.
- Application
- ANDA089805
- Marketing category
- ANDA
- Marketing start
- 2002-05-03
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 300 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 12634-526-00 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 10 in 1 BOTTLE | TABLET | 10 | | 8 |
| 12634-526-01 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 12634-526-40 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 40 in 1 BOTTLE | TABLET | 40 | | 8 |
| 12634-526-50 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 50 in 1 BOTTLE | TABLET | 50 | | 8 |
| 12634-526-55 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 15 in 1 BLISTER PACK | TABLET | 15 | | 8 |
| 12634-526-59 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 30 in 1 BLISTER PACK | TABLET | 30 | | 8 |
| 12634-526-65 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 5 in 1 BLISTER PACK | TABLET | 5 | | 8 |
| 12634-526-66 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 6 in 1 BLISTER PACK | TABLET | 6 | | 8 |
| 12634-526-71 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 30 in 1 BOTTLE | TABLET | 30 | | 8 |
| 12634-526-80 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 20 in 1 BOTTLE | TABLET | 20 | | 8 |
| 12634-526-82 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 12 in 1 BOTTLE | TABLET | 12 | | 8 |
| 12634-526-85 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 15 in 1 BOTTLE | TABLET | 15 | | 8 |
| 12634-526-91 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 1 in 1 BLISTER PACK | TABLET | 1 | | 8 |
| 12634-526-94 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 4 in 1 BOTTLE | TABLET | 4 | | 8 |
| 12634-526-96 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 6 in 1 BOTTLE | TABLET | 6 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.] | 3 | |
| CODEINE PHOSPHATE | ACTIVE INGREDIENT | GSL05Y1MN6 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.] | 3 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.] | 3 | |
| CODEINE ANHYDROUS | ACTIVE MOIETY | UX6OWY2V7J | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.] | 3 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 12634-526 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET [APOTHECA, INC.] | 8 | Legacy NDC, 15 package rows | 20160120_909b5ad2-c78d-431c-a725-31fe02a2b21d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 12634-526-00 | 12634052600 | 10 in 1 BOTTLE | Historical |
| 12634-526-01 | 12634052601 | 100 in 1 BOTTLE | Historical |
| 12634-526-40 | 12634052640 | 40 in 1 BOTTLE | Historical |
| 12634-526-50 | 12634052650 | 50 in 1 BOTTLE | Historical |
| 12634-526-55 | 12634052655 | 15 in 1 BLISTER PACK | Historical |
| 12634-526-59 | 12634052659 | 30 in 1 BLISTER PACK | Historical |
| 12634-526-65 | 12634052665 | 5 in 1 BLISTER PACK | Historical |
| 12634-526-66 | 12634052666 | 6 in 1 BLISTER PACK | Historical |
| 12634-526-71 | 12634052671 | 30 in 1 BOTTLE | Historical |
| 12634-526-80 | 12634052680 | 20 in 1 BOTTLE | Historical |
| 12634-526-82 | 12634052682 | 12 in 1 BOTTLE | Historical |
| 12634-526-85 | 12634052685 | 15 in 1 BOTTLE | Historical |
| 12634-526-91 | 12634052691 | 1 in 1 BLISTER PACK | Historical |
| 12634-526-94 | 12634052694 | 4 in 1 BOTTLE | Historical |
| 12634-526-96 | 12634052696 | 6 in 1 BOTTLE | Historical |