FDA.reportPublic FDA data

Phentermine

Product NDC
13107-106
11-digit product format
131070106
Labeler code
13107
Product ID
13107-106_53dd7857-41fb-4da1-88f7-5c68a509bfb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurolife Pharma, LLC
Application
ANDA204318
Marketing category
ANDA
Marketing start
2017-03-20
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
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 · 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
ndc (product): 13107-106

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE30 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
900038Internal RxNorm lookup
968766Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
737eef3b-9a6b-4ab3-a25c-49d84d2a0197Available 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
13107-106-01Phentermine100 in 1 BOTTLECAPSULE1004
13107-106-30Phentermine30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-106-01EA - Each13107-10614a801e9-ab85-48d6-b5de-1d0066391c2512017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-106PHENTERMINE (PHENTERMINE HYDROCHLORIDE) CAPSULE [AUROLIFE PHARMA, LLC]4Current NDC, Legacy NDC, 2 package rows20190108_737eef3b-9a6b-4ab3-a25c-49d84d2a0197.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
968766phentermine HCl 15 MG Oral CapsulePSN737eef3b-9a6b-4ab3-a25c-49d84d2a01974
900038phentermine HCl 30 MG Oral CapsulePSN737eef3b-9a6b-4ab3-a25c-49d84d2a01974
968766phentermine hydrochloride 15 MG Oral CapsuleSCD737eef3b-9a6b-4ab3-a25c-49d84d2a01974
900038phentermine hydrochloride 30 MG Oral CapsuleSCD737eef3b-9a6b-4ab3-a25c-49d84d2a01974
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY737eef3b-9a6b-4ab3-a25c-49d84d2a01974
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY737eef3b-9a6b-4ab3-a25c-49d84d2a01974

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-106-0113107010601100 CAPSULE in 1 BOTTLE (13107-106-01) 100 capsule2017-03-200000-00-00NoNoCurrent
13107-106-301310701063030 CAPSULE in 1 BOTTLE (13107-106-30) 30 capsule2017-03-200000-00-00NoNoCurrent