FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
68382-670
Requested package NDC
68382-670-06
11-digit product format
683820670
Labeler code
68382
Product ID
68382-670_80a20fab-b983-406b-a7e2-10b50f38e512
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA204663
Marketing category
ANDA
Marketing start
2018-02-08
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68382-67068382-670-06DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68382-67068382-670-06DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68382-67068382-670-06DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204663-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE15MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28
A204663-002PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE30MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28
A204663-003PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE37.5MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A204663-001PHENTERMINE HYDROCHLORIDE15MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28c2088c7a36db…
2026-10-15 13:18:302026-09A204663-002PHENTERMINE HYDROCHLORIDE30MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28c2088c7a36db…
2026-10-15 13:18:302026-09A204663-003PHENTERMINE HYDROCHLORIDE37.5MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28c2088c7a36db…
2026-09-14 22:38:342026-08A204663-001PHENTERMINE HYDROCHLORIDE15MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-2884e616aacf4f…
2026-09-14 22:38:342026-08A204663-002PHENTERMINE HYDROCHLORIDE30MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-2884e616aacf4f…
2026-09-14 22:38:342026-08A204663-003PHENTERMINE HYDROCHLORIDE37.5MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-2884e616aacf4f…
2026-08-18 06:07:402026-07A204663-001PHENTERMINE HYDROCHLORIDE15MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A204663-002PHENTERMINE HYDROCHLORIDE30MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A204663-003PHENTERMINE HYDROCHLORIDE37.5MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204663-001PHENTERMINE HYDROCHLORIDE15MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204663-002PHENTERMINE HYDROCHLORIDE30MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204663-003PHENTERMINE HYDROCHLORIDE37.5MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204663-001PHENTERMINE HYDROCHLORIDE15MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204663-002PHENTERMINE HYDROCHLORIDE30MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204663-003PHENTERMINE HYDROCHLORIDE37.5MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A204663-001PHENTERMINE HYDROCHLORIDE15MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204663-002PHENTERMINE HYDROCHLORIDE30MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204663-003PHENTERMINE HYDROCHLORIDE37.5MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204663-001PHENTERMINE HYDROCHLORIDE15MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204663-002PHENTERMINE HYDROCHLORIDE30MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204663-003PHENTERMINE HYDROCHLORIDE37.5MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204663-001PHENTERMINE HYDROCHLORIDE15MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204663-002PHENTERMINE HYDROCHLORIDE30MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204663-003PHENTERMINE HYDROCHLORIDE37.5MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204663-001PHENTERMINE HYDROCHLORIDE15MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204663-002PHENTERMINE HYDROCHLORIDE30MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204663-003PHENTERMINE HYDROCHLORIDE37.5MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204663-001PHENTERMINE HYDROCHLORIDE15MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204663-002PHENTERMINE HYDROCHLORIDE30MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204663-003PHENTERMINE HYDROCHLORIDE37.5MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204663-001PHENTERMINE HYDROCHLORIDE15MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204663-002PHENTERMINE HYDROCHLORIDE30MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204663-003PHENTERMINE HYDROCHLORIDE37.5MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204663-001PHENTERMINE HYDROCHLORIDE15MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204663-002PHENTERMINE HYDROCHLORIDE30MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204663-003PHENTERMINE HYDROCHLORIDE37.5MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204663-001PHENTERMINE HYDROCHLORIDE15MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A204663-002PHENTERMINE HYDROCHLORIDE30MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A204663-003PHENTERMINE HYDROCHLORIDE37.5MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204663-001PHENTERMINE HYDROCHLORIDE15MGTABLET, ORALLY DISINTEGRATING / ORAL2017-06-2879d66fd596c7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-670-066838206700630 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-670-06) 2018-02-080000-00-00NoNoCurrent