FDA.reportPublic FDA data

Phentermine

Product NDC
50090-3306
Requested package NDC
50090-3306-4
11-digit product format
500903306
Labeler code
50090
Product ID
50090-3306_49c1d86e-31b5-4e02-9cd0-5780cd564df1
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
30 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-330650090-3306-4DDiscontinued 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3306-0Phentermine30 in 1 BOTTLECAPSULE3016
50090-3306-4Phentermine28 in 1 BOTTLECAPSULE2816

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3306-0EA - Each50090-330676b42ea8-59d0-417b-8cb5-099f42ba1a1112018-10-11
50090-3306-4EA - Each50090-330696b73634-99cd-4695-bc5e-665c98c5b3a012018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3306PHENTERMINE (PHENTERMINE HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]16Legacy NDC, 2 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
50090-3306-45009033060428 CAPSULE in 1 BOTTLE (50090-3306-4) 28 capsule2018-04-300000-00-00NoNoCurrent