Acetaminophen, Caffeine, Dihydrocodeine Bitartrate
- Product NDC
- 42195-840
- 11-digit product format
- 421950840
- Labeler code
- 42195
- Product ID
- 42195-840_8f97e457-8e1b-40fd-944c-f3806d9cc1d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Acetaminophen, Caffeine, Dihydrocodeine Bitartrate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Xspire Pharma, Llc
- Application
- ANDA204785
- Marketing category
- ANDA
- Marketing start
- 2015-08-05
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
- Active strength
- 321 mg/1; mg/1; mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| 42195-840-10 | Acetaminophen, Caffeine, Dihydrocodeine Bitartrate | 100 in 1 BOTTLE | CAPSULE | 100 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC] | 1 | |
| CAFFEINE | ACTIVE INGREDIENT | 3G6A5W338E | ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC] | 1 | |
| DIHYDROCODEINE BITARTRATE | ACTIVE INGREDIENT | 8LXS95BSA9 | ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC] | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC] | 1 | |
| CAFFEINE | ACTIVE MOIETY | 3G6A5W338E | ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC] | 1 | |
| DIHYDROCODEINE | ACTIVE MOIETY | N9I9HDB855 | ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC] | 1 | |
| CROSPOVIDONE (15 MPA.S AT 5%) | INACTIVE INGREDIENT | 68401960MK | ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42195-840 | ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA, LLC] | 3 | Legacy NDC, 1 package rows | 20210203_76e033b0-01c1-42df-bb64-f8ca401cfb6b.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 |
|---|
| 42195-840-10 | 42195084010 | 100 CAPSULE in 1 BOTTLE (42195-840-10) | 100 capsule | 2015-08-05 | 0000-00-00 | No | No | Current |