DVORAH
- Product NDC
- 70362-730
- 11-digit product format
- 703620730
- Labeler code
- 70362
- Product ID
- 70362-730_b45337da-a6d8-a563-e053-2a95a90a115a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen, caffeine and dihydrocodeine bitartrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Skylar Laboratories, LLC
- Application
- ANDA204209
- Marketing category
- ANDA
- Marketing start
- 2018-12-06
- Marketing end
- 2021-03-11
- Substance
- ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
- Active strength
- 325 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 70362-730 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 70362-730 | 70362-730-01 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 70362-730 | 70362-730-30 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A204209-001 | ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE | ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE | 325MG;30MG;16MG | TABLET / ORAL | | | 2016-09-30 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70362-730-01 | 70362073001 | 100 TABLET in 1 BOTTLE (70362-730-01) | 100 tablet | 2018-12-06 | 2021-03-11 | No | No | Current |
| 70362-730-30 | 70362073030 | 30 TABLET in 1 BOTTLE (70362-730-30) | 30 tablet | 2018-12-06 | 2021-03-11 | No | No | Current |