Phentermine Hydrochloride
- Product NDC
- 50436-0101
- 11-digit product format
- 504360101
- Labeler code
- 50436
- Product ID
- 50436-0101_be940118-c564-4aea-acec-d539b56e2a0c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phentermine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA200272
- Marketing category
- ANDA
- Marketing start
- 2011-03-08
- Marketing end
- 0000-00-00
- Substance
- PHENTERMINE HYDROCHLORIDE
- Active strength
- 38 mg/1
- Pharmacologic classes
- Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
- DEA schedule
- CIV
- 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#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50436-0101-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-b36f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets, USP. Phentermine Hydrochloride Tablets, USP CIV for oral use Initial U.S. Approval: 1959 |
| 50436-0101-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-b36f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets, USP. Phentermine Hydrochloride Tablets, USP CIV for oral use Initial U.S. Approval: 1959 |
| 50436-0101-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-b36f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets, USP. Phentermine Hydrochloride Tablets, USP CIV for oral use Initial U.S. Approval: 1959 |
| 50436-0101-4 | 2023-01-30 | C162847 | 48780-1 | f386c649-b36f-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets, USP. Phentermine Hydrochloride Tablets, USP CIV for oral use Initial U.S. Approval: 1959 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50436-0101-1 | Phentermine Hydrochloride | 7 in 1 BOTTLE | TABLET | 7 | | 1 |
| 50436-0101-2 | Phentermine Hydrochloride | 14 in 1 BOTTLE | TABLET | 14 | | 1 |
| 50436-0101-3 | Phentermine Hydrochloride | 21 in 1 BOTTLE | TABLET | 21 | | 1 |
| 50436-0101-4 | Phentermine Hydrochloride | 28 in 1 BOTTLE | TABLET | 28 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50436-0101 | PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES] | 1 | Legacy NDC, 4 package rows | 20210808_bfc81014-a516-411a-802d-fedfa038c413.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 |
|---|
| 50436-0101-1 | 50436010101 | 7 TABLET in 1 BOTTLE (50436-0101-1) | 7 tablet | 2021-08-06 | 0000-00-00 | No | No | Current |
| 50436-0101-2 | 50436010102 | 14 TABLET in 1 BOTTLE (50436-0101-2) | 14 tablet | 2021-08-06 | 0000-00-00 | No | No | Current |
| 50436-0101-3 | 50436010103 | 21 TABLET in 1 BOTTLE (50436-0101-3) | 21 tablet | 2021-08-06 | 0000-00-00 | No | No | Current |
| 50436-0101-4 | 50436010104 | 28 TABLET in 1 BOTTLE (50436-0101-4) | 28 tablet | 2021-08-06 | 0000-00-00 | No | No | Current |