Lortab
- Product NDC
- 17478-450
- 11-digit product format
- 174780450
- Labeler code
- 17478
- Product ID
- 17478-450_96184148-9ff5-4e89-b399-ef55858a23ec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Akorn
- Application
- ANDA040881
- Marketing category
- ANDA
- Marketing start
- 2015-03-17
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 300 mg/15mL; mg/15mL
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17478-450-16 | 2025-01-14 | C162847 | 48780-1 | 1030e365-4632-111a-e063-dadaa90a10e2 | 21def91d-b6e3-4dde-983c-6925aedf0df0 |
| 17478-450-16 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4632-111a-e063-dadaa90a10e2 | 21def91d-b6e3-4dde-983c-6925aedf0df0 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17478-450-16 | ML - Milliliter | 17478-450 | c384ac5d-40b9-4519-a96e-f0a30b69f2d9 | 1 | 2015-07-20 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1044427 | HYDROcodone bitartrate 10 MG / acetaminophen 300 MG in 15 mL Oral Solution | PSN | 34fddb2d-ccc5-4189-ac2a-146b46c447f6 | 2 |
| 1442445 | LORTAB 10 MG / 300 MG in 15 mL Oral Solution | PSN | 34fddb2d-ccc5-4189-ac2a-146b46c447f6 | 2 |
| 1442445 | acetaminophen 20 MG/ML / hydrocodone bitartrate 0.667 MG/ML Oral Solution [Lortab] | SBD | 34fddb2d-ccc5-4189-ac2a-146b46c447f6 | 2 |
| 1044427 | acetaminophen 20 MG/ML / hydrocodone bitartrate 0.667 MG/ML Oral Solution | SCD | 34fddb2d-ccc5-4189-ac2a-146b46c447f6 | 2 |
| 1044427 | APAP 20 MG/ML / Hydrocodone Bitartrate 0.667 MG/ML Oral Solution | SY | 34fddb2d-ccc5-4189-ac2a-146b46c447f6 | 2 |
| 1442445 | APAP 20 MG/ML / Hydrocodone Bitartrate 0.667 MG/ML Oral Solution [Lortab] | SY | 34fddb2d-ccc5-4189-ac2a-146b46c447f6 | 2 |
| 1044427 | APAP 300 MG / hydrocodone bitartrate 10 MG per 15 ML Oral Solution | SY | 34fddb2d-ccc5-4189-ac2a-146b46c447f6 | 2 |
| 1442445 | Lortab (acetaminophen 300 MG / hydrocodone bitartrate 10 MG) per 15 ML Oral Solution | SY | 34fddb2d-ccc5-4189-ac2a-146b46c447f6 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 17478-450-16 | 17478045016 | 473 mL in 1 BOTTLE, PLASTIC (17478-450-16) | 473 ml | 2015-03-17 | 0000-00-00 | No | No | Current |