FDA.reportPublic FDA data

Phentermine

Product NDC
50090-3282
11-digit product format
500903282
Labeler code
50090
Product ID
50090-3282_d7050da0-f45b-4b9b-a312-aa70cbfe730b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204318
Marketing category
ANDA
Marketing start
2017-03-20
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
15 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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-3282IInactivated by FDA2026-08-03
excluded packagepackage50090-328250090-3282-0IInactivated by FDA2026-08-03
excluded packagepackage50090-328250090-3282-2IInactivated by FDA2026-08-03
excluded packagepackage50090-328250090-3282-4IInactivated by FDA2026-08-03
excluded packagepackage50090-328250090-3282-5DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204318-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2016-11-09
A204318-002PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2016-11-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A204318-001AA
A204318-002AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A204318-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2016-11-09a50c72e98297…
2026-08-01 22:54:322026-06A204318-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2016-11-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204318-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A204318-002AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhenterminePHENTERMINE HYDROCHLORIDEAurolife Pharma, LLC737eef3b-9a6b-4ab3-a25c-49d84d2a01972019-01-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204318
application number: ANDA204318

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303
32c2b0bd-1f13-4890-99e0-dcd2ea16e1abProduct name220230717
ebeae3eb-385d-62da-8827-5ffa80b14e90Product name220170810
1d682039-1122-1cb7-f3f4-c0a028b98748Product name420170124
8ef9ca65-1a6c-7225-351d-36066d0f8e56Product name320161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3282-02023-01-30C16284748780-1f386c649-ee51-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP CIV safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP PHENTERMINE hydrochloride capsules, for oral use Initial U.S. Approval: 1959
50090-3282-22023-01-30C16284748780-1f386c649-ee51-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP CIV safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP PHENTERMINE hydrochloride capsules, for oral use Initial U.S. Approval: 1959
50090-3282-42023-01-30C16284748780-1f386c649-ee51-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP CIV safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP PHENTERMINE hydrochloride capsules, for oral use Initial U.S. Approval: 1959
50090-3282-52023-01-30C16284748780-1f386c649-ee51-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP CIV safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP PHENTERMINE hydrochloride capsules, for oral use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3282-0Phentermine28 in 1 BOTTLECAPSULE2816
50090-3282-2Phentermine14 in 1 BOTTLE, PLASTICCAPSULE1416
50090-3282-4Phentermine30 in 1 BOTTLECAPSULE3016
50090-3282-5Phentermine60 in 1 BOTTLECAPSULE6016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3282-0EA - Each50090-3282b00f44b0-9c2c-4c54-8c5f-bad13ea3811f12018-11-06
50090-3282-2EA - Each50090-32827299df16-c3e8-4534-bf25-39fa5e844de312021-09-07
50090-3282-4EA - Each50090-3282c5acbc28-4714-4f6b-a395-90c734c891b812018-11-06
50090-3282-5EA - Each50090-3282338c92fb-5af5-47a9-a449-e25ded93d57612018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3282PHENTERMINE (PHENTERMINE HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]16Legacy NDC, 4 package rows20210818_8229adf5-b128-41a5-a3cc-16db4001801c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSN8229adf5-b128-41a5-a3cc-16db4001801c16
900038phentermine HCl 30 MG Oral CapsulePSN8229adf5-b128-41a5-a3cc-16db4001801c16
968766phentermine hydrochloride 15 MG Oral CapsuleSCD8229adf5-b128-41a5-a3cc-16db4001801c16
900038phentermine hydrochloride 30 MG Oral CapsuleSCD8229adf5-b128-41a5-a3cc-16db4001801c16
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY8229adf5-b128-41a5-a3cc-16db4001801c16
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY8229adf5-b128-41a5-a3cc-16db4001801c16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3282-05009032820028 CAPSULE in 1 BOTTLE (50090-3282-0) 28 capsule2017-11-290000-00-00NoNoCurrent
50090-3282-25009032820214 CAPSULE in 1 BOTTLE, PLASTIC (50090-3282-2) 14 capsule2017-03-200000-00-00NoNoCurrent
50090-3282-45009032820430 CAPSULE in 1 BOTTLE (50090-3282-4) 30 capsule2018-01-030000-00-00NoNoCurrent
50090-3282-55009032820560 CAPSULE in 1 BOTTLE (50090-3282-5) 60 capsule2017-11-270000-00-00NoNoCurrent