Phentermine Hydrochloride

Product NDC
51224-203
11-digit product format
512240203
Labeler code
51224
Product ID
51224-203_6bb9aac7-67f6-4338-bb57-2608fa4a1467
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
TAGI Pharma, Inc
Application
ANDA202248
Marketing category
ANDA
Marketing start
2012-02-17
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
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51224-203DDiscontinued by firm2026-08-07
excluded packagepackage51224-20351224-203-50DDiscontinued by firm2026-08-07
excluded packagepackage51224-20351224-203-70DDiscontinued by firm2026-08-07

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
A202248-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28
A202248-002PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202248-001AA
A202248-002AA

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 UTC2026-02A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202248-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2012-09-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A202248-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2012-09-28782e0a99824c…

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 UTC2026-02A202248-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202248-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202248-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202248-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202248-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202248-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202248-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202248-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202248-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202248-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202248-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202248-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202248-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202248-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202248-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202248-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202248-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202248-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202248-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202248-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202248-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202248-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202248-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202248-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202248-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202248-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202248-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202248-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202248-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202248-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202248-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202248-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202248-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202248-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202248-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202248-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202248-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202248-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202248-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202248-002AA1782e0a99824c…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51224-203-50EA - Each51224-203e636e03e-e903-42d9-b92e-75dfbbe6d04512013-05-02
51224-203-70EA - Each51224-203294279ef-7c90-46f4-8225-7eec1722006c12013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phentermine HydrochlorideACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE CAPSULE [TAGI PHARMA, INC.]1
PhentermineACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE CAPSULE [TAGI PHARMA, INC.]1
D&C yellow No. 10INACTIVE INGREDIENT35SW5USQ3GPHENTERMINE HYDROCHLORIDE CAPSULE [TAGI PHARMA, INC.]1
FD&C blue No. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE CAPSULE [TAGI PHARMA, INC.]1
FD&C red No. 3INACTIVE INGREDIENTPN2ZH5LOQYPHENTERMINE HYDROCHLORIDE CAPSULE [TAGI PHARMA, INC.]1
FD&C red No. 40INACTIVE INGREDIENTWZB9127XOAPHENTERMINE HYDROCHLORIDE CAPSULE [TAGI PHARMA, INC.]1
gelatinINACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE CAPSULE [TAGI PHARMA, INC.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE CAPSULE [TAGI PHARMA, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE CAPSULE [TAGI PHARMA, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE CAPSULE [TAGI PHARMA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51224-203PHENTERMINE HYDROCHLORIDE CAPSULE [TAGI PHARMA, INC]10Legacy NDC20250503_2acb0c69-0089-4817-86ad-6df592c0356e.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackd95e14f7-a46d-47fa-8dab-ee3d8d4c7b6d2026-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b425840f-380e-42bd-852a-6ee3641977ce2026-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacke48feec6-50c9-4ccd-b9da-56956d14c8532026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEMartek Pharmacal Co.1149f69d-65df-6a98-e063-6394a90aeaa42026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackd76940d3-95e6-442d-99ef-4fe92de7a3762025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPrecision Dose Inc.095a2be5-721e-46e6-976f-9137c855cd222025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack723c37c4-868f-40f0-b74d-137dcbb93f9f2025-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions8c7c1391-bfd1-48f9-b249-9729fe648b892023-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202248
application number: ANDA202248

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSN486b9a91-e990-4150-a976-28d54103828f102
968766phentermine hydrochloride 15 MG Oral CapsuleSCD486b9a91-e990-4150-a976-28d54103828f102
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY486b9a91-e990-4150-a976-28d54103828f102
968766phentermine HCl 15 MG Oral CapsulePSN723c37c4-868f-40f0-b74d-137dcbb93f9f12
900038phentermine HCl 30 MG Oral CapsulePSN723c37c4-868f-40f0-b74d-137dcbb93f9f12
968766phentermine hydrochloride 15 MG Oral CapsuleSCD723c37c4-868f-40f0-b74d-137dcbb93f9f12
900038phentermine hydrochloride 30 MG Oral CapsuleSCD723c37c4-868f-40f0-b74d-137dcbb93f9f12
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY723c37c4-868f-40f0-b74d-137dcbb93f9f12
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSY723c37c4-868f-40f0-b74d-137dcbb93f9f12
968766phentermine HCl 15 MG Oral CapsulePSNb62e46eb-53f3-44df-899b-dbb8ca3222a89
900038phentermine HCl 30 MG Oral CapsulePSNb62e46eb-53f3-44df-899b-dbb8ca3222a89
968766phentermine hydrochloride 15 MG Oral CapsuleSCDb62e46eb-53f3-44df-899b-dbb8ca3222a89
900038phentermine hydrochloride 30 MG Oral CapsuleSCDb62e46eb-53f3-44df-899b-dbb8ca3222a89
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSYb62e46eb-53f3-44df-899b-dbb8ca3222a89
900038phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral CapsuleSYb62e46eb-53f3-44df-899b-dbb8ca3222a89
968766phentermine HCl 15 MG Oral CapsulePSN0cddd461-d824-41b6-ac9e-b47c342274332
968766phentermine hydrochloride 15 MG Oral CapsuleSCD0cddd461-d824-41b6-ac9e-b47c342274332
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSY0cddd461-d824-41b6-ac9e-b47c342274332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51224-203-5051224020350100 CAPSULE in 1 BOTTLE (51224-203-50) 100 capsule2012-02-170000-00-00NoNoCurrent
51224-203-70512240203701000 CAPSULE in 1 BOTTLE (51224-203-70) 1000 capsule2012-02-170000-00-00NoNoCurrent