Phentermine Hydrochloride

Product NDC
17224-870
11-digit product format
172240870
Labeler code
17224
Product ID
17224-870_f8aba3a2-7dc5-fb9a-e053-6294a90ad49e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENTERMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Calvin Scott & Co., Inc.
Application
ANDA040886
Marketing category
ANDA
Marketing start
2012-08-07
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
A040886-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31
A040886-002PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040886-001AA
A040886-002AA

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040886-001PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2008-03-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A040886-002PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2008-03-31782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040886-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040886-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040886-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040886-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040886-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040886-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040886-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040886-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040886-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040886-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040886-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040886-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040886-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040886-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040886-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040886-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040886-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040886-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040886-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040886-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040886-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040886-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040886-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040886-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040886-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040886-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040886-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040886-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040886-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040886-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040886-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040886-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040886-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040886-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040886-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040886-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040886-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040886-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040886-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040886-002AA1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine Hydrochloride
Listing expiration
2027-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2f3b738f-d66b-40c1-8e69-bcd50bce3e47Available 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
17224-870-21Phentermine Hydrochloride21 in 1 BOTTLECAPSULE211
17224-870-28Phentermine Hydrochloride28 in 1 BOTTLECAPSULE281
17224-870-30Phentermine Hydrochloride30 in 1 BOTTLECAPSULE301
17224-870-42Phentermine Hydrochloride42 in 1 BOTTLECAPSULE421

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17224-870PHENTERMINE HYDROCHLORIDE CAPSULE [CALVIN SCOTT & CO., INC.]1Current NDC, 4 package rows20230407_2f3b738f-d66b-40c1-8e69-bcd50bce3e47.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.2f3b738f-d66b-40c1-8e69-bcd50bce3e472026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
ndc (product): 17224-870
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.4000c00f-aa6c-4ea5-af0e-149dde3c74db2025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f115ad6d-cf62-40e7-89d1-6183a9b5071f2025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2abc445c-daa8-7326-e054-00144ff88e882025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions5234cabd-6b3e-404d-a0cd-256ee5fcc8f12025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEMartek Pharmacal Co.1fe86035-19ef-4944-ad81-c0167a8e7fec2025-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEMartek Pharmacal Co.1a8b3c4a-f7fe-5cc9-e063-6394a90a90dd2025-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.0b4d847a-fcda-df31-e063-6294a90a0c5e2025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack7f1c3a5d-dd9b-4441-a483-aa5777f8e40c2024-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEKVK-Tech, Inc.b963f7bb-fa65-4e28-81c9-282fbe70a6a62024-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LP3a3259ec-ded3-427f-843d-928d130de3da2020-03-01Adverse reactionsExact identifier
application applno (ANDA): 040886
application number: ANDA040886

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900038phentermine HCl 30 MG Oral CapsulePSN2f3b738f-d66b-40c1-8e69-bcd50bce3e472
900038phentermine hydrochloride 30 MG Oral CapsuleSCD2f3b738f-d66b-40c1-8e69-bcd50bce3e472
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY2f3b738f-d66b-40c1-8e69-bcd50bce3e472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17224-870-141722408701414 CAPSULE in 1 BOTTLE (17224-870-14)14 capsule2012-08-070Current
17224-870-211722408702121 CAPSULE in 1 BOTTLE (17224-870-21) 21 capsule2012-08-07NoNoCurrent
17224-870-281722408702828 CAPSULE in 1 BOTTLE (17224-870-28) 28 capsule2012-08-07NoNoCurrent
17224-870-301722408703030 CAPSULE in 1 BOTTLE (17224-870-30) 30 capsule2012-08-07NoNoCurrent
17224-870-421722408704242 CAPSULE in 1 BOTTLE (17224-870-42) 42 capsule2012-08-07NoNoCurrent