FDA.reportPublic FDA data

Phentermine Hydrochloride

Product NDC
13107-061
11-digit product format
131070061
Labeler code
13107
Product ID
13107-061_0add1627-bf2b-40ba-b5a4-1cf580496a38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurolife Pharma, LLC
Application
ANDA203068
Marketing category
ANDA
Marketing start
2014-08-06
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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203068-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203068-001AA

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 22:54:322026-06A203068-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2014-08-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203068-001AA1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEAurolife Pharma LLC5927e0f6-3de3-4885-a633-5b92003f6fe42026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203068
application number: ANDA203068
ndc (product): 13107-061
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDIRECT RXc3dda0a4-b428-f3e7-e053-2995a90ad1062025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203068
application number: ANDA203068
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LPb3c48b3c-fab7-4ea4-93b0-b108979e9da32022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203068
application number: ANDA203068

Additional Listing Data#

Finished product
Yes
Brand name base
PHENTERMINE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE37.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0K2I505OTVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
803353Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5927e0f6-3de3-4885-a633-5b92003f6fe4Available on FDA.report

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
13107-061-01Phentermine Hydrochloride100 in 1 BOTTLETABLET1007
13107-061-05Phentermine Hydrochloride500 in 1 BOTTLETABLET5007
13107-061-30Phentermine Hydrochloride30 in 1 BOTTLETABLET307
13107-061-99Phentermine Hydrochloride1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-061-01EA - Each13107-06138507f77-2f41-48f9-a38c-1bb4409a8ec612014-11-05
13107-061-99EA - Each13107-06197bc379f-712f-43c6-9ef0-677e7ac4680312014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC]5
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC]5
SUCROSEINACTIVE INGREDIENTC151H8M554PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE ) TABLET [AUROLIFE PHARMA, LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-061PHENTERMINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC]7Current NDC, Legacy NDC, 4 package rows20190110_5927e0f6-3de3-4885-a633-5b92003f6fe4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
803353phentermine HCl 37.5 MG Oral TabletPSN5927e0f6-3de3-4885-a633-5b92003f6fe47
803353phentermine hydrochloride 37.5 MG Oral TabletSCD5927e0f6-3de3-4885-a633-5b92003f6fe47
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY5927e0f6-3de3-4885-a633-5b92003f6fe47
803353phentermine HCl 37.5 MG Oral TabletPSNb3c48b3c-fab7-4ea4-93b0-b108979e9da36
803353phentermine hydrochloride 37.5 MG Oral TabletSCDb3c48b3c-fab7-4ea4-93b0-b108979e9da36
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYb3c48b3c-fab7-4ea4-93b0-b108979e9da36
803353phentermine HCl 37.5 MG Oral TabletPSN1d1d27e7-7ef9-4c74-809a-6951112084305
803353phentermine hydrochloride 37.5 MG Oral TabletSCD1d1d27e7-7ef9-4c74-809a-6951112084305
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY1d1d27e7-7ef9-4c74-809a-6951112084305
803353phentermine HCl 37.5 MG Oral TabletPSNc3dda0a4-b428-f3e7-e053-2995a90ad1062
803353phentermine hydrochloride 37.5 MG Oral TabletSCDc3dda0a4-b428-f3e7-e053-2995a90ad1062
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSYc3dda0a4-b428-f3e7-e053-2995a90ad1062
803353phentermine HCl 37.5 MG Oral TabletPSN7d633912-6178-b99b-e053-2a91aa0af59a1
803353phentermine hydrochloride 37.5 MG Oral TabletSCD7d633912-6178-b99b-e053-2a91aa0af59a1
803353phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral TabletSY7d633912-6178-b99b-e053-2a91aa0af59a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-061-0113107006101100 TABLET in 1 BOTTLE (13107-061-01) 100 tablet2014-08-060000-00-00NoNoCurrent
13107-061-0513107006105500 TABLET in 1 BOTTLE (13107-061-05) 500 tablet2014-08-060000-00-00NoNoCurrent
13107-061-301310700613030 TABLET in 1 BOTTLE (13107-061-30) 30 tablet2014-08-060000-00-00NoNoCurrent
13107-061-99131070061991000 TABLET in 1 BOTTLE (13107-061-99) 1000 tablet2014-08-060000-00-00NoNoCurrent