Phentermine hydrochloride
- Product NDC
- 52605-022
- 11-digit product format
- 526050022
- Labeler code
- 52605
- Product ID
- 52605-022_995d657e-4998-40cd-8a58-a6574fb91ba9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phentermine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- POLYGEN PHARMACEUTICALS INC.
- Application
- ANDA206342
- Marketing category
- ANDA
- Marketing start
- 2016-11-18
- Substance
- PHENTERMINE HYDROCHLORIDE
- Active strength
- 37.5 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Phentermine hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHENTERMINE HYDROCHLORIDE | 37.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0K2I505OTV |
| Rxcui | 803353 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 52605-022-01 | 2025-12-09 | C162847 | 48780-1 | 9d75b9d0-aea9-f424-e053-dadaa90a57ce | 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, for oral use CIV Initial U.S. Approval: 1959 |
| 52605-022-10 | 2025-12-09 | C162847 | 48780-1 | 9d75b9d0-aea9-f424-e053-dadaa90a57ce | 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, for oral use CIV Initial U.S. Approval: 1959 |
| 52605-022-01 | 2022-01-28 | C162847 | 48780-1 | 9d75b9d0-aea9-f424-e053-dadaa90a57ce | 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, for oral use CIV Initial U.S. Approval: 1959 |
| 52605-022-10 | 2022-01-28 | C162847 | 48780-1 | 9d75b9d0-aea9-f424-e053-dadaa90a57ce | 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, for oral use CIV Initial U.S. Approval: 1959 |
| 52605-022-01 | 2020-10-22 | C162847 | 48780-1 | 9d75b9d0-aea9-f424-e053-dadaa90a57ce | 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, for oral use CIV Initial U.S. Approval: 1959 |
| 52605-022-10 | 2020-10-22 | C162847 | 48780-1 | 9d75b9d0-aea9-f424-e053-dadaa90a57ce | 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, for oral use CIV Initial U.S. Approval: 1959 |
| 52605-022-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-aea9-f424-e053-dadaa90a57ce | 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, for oral use CIV Initial U.S. Approval: 1959 |
| 52605-022-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-aea9-f424-e053-dadaa90a57ce | 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, for oral use CIV Initial U.S. Approval: 1959 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52605-022-01 | Phentermine hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
| 52605-022-10 | Phentermine hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52605-022 | PHENTERMINE HYDROCHLORIDE TABLET [POLYGEN PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20201022_e47dc31f-9548-403e-940f-a5380f938aed.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 |
|---|
| 52605-022-01 | 52605002201 | 100 TABLET in 1 BOTTLE (52605-022-01) | 100 tablet | 2016-11-18 | 0000-00-00 | No | No | Current |
| 52605-022-10 | 52605002210 | 1000 TABLET in 1 BOTTLE (52605-022-10) | 1000 tablet | 2016-11-18 | 0000-00-00 | No | No | Current |