Phentermine HCL C-IV

Product NDC
72189-365
11-digit product format
721890365
Labeler code
72189
Product ID
72189-365_2c4c9dee-895f-30b5-e063-6394a90a3523
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine HCL C-IV
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA205019
Marketing category
ANDA
Marketing start
2022-07-25
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
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-365-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-365-300efc9e666f02…f202fb6c5f17…

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
A205019-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-05
A205019-002PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205019-001AA
A205019-002AA

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 UTC2026-02A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205019-001PHENTERMINE HYDROCHLORIDE15MGCAPSULE / ORALAA2014-12-05782e0a99824c…
2021-12-28 21:50 UTC2021-12A205019-002PHENTERMINE HYDROCHLORIDE30MGCAPSULE / ORALAA2014-12-05782e0a99824c…

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 UTC2026-02A205019-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205019-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205019-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205019-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205019-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205019-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205019-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205019-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205019-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205019-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205019-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205019-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205019-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205019-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205019-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205019-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205019-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205019-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205019-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205019-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205019-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205019-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205019-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205019-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205019-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205019-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205019-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205019-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205019-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205019-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205019-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205019-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205019-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205019-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205019-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205019-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205019-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205019-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205019-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A205019-002AA1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENTERMINE HYDROCHLORIDE15 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
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
e4a2996e-2bfa-376f-e053-2995a90a0ed1Available 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
72189-365-30Phentermine HCL C-IV30 in 1 BOTTLECAPSULE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-365-30EA - Each72189-365907a30b0-3bf4-4696-b974-9ec2317617bf12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-365PHENTERMINE HCL C-IV CAPSULE [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20250123_e4a2996e-2bfa-376f-e053-2995a90a0ed1.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.130e6087-0ab6-4456-a781-d370f363dc382026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.d24aaa53-9c78-4c1b-9495-c785a9cf2b262026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutionsc53bd3c5-01f6-4a21-9e3c-aa4969a01b4b2026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackfa5de92d-a5bf-4ae1-8e13-ad827aeebea32026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacka9270c14-499f-4c07-a1eb-c0aab5d8731f2025-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.d77f31b4-7e36-4a0a-a55b-78b4b6ab5cb72025-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.70bc6f36-8087-4ccd-a396-a911c0ebae792025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack640d71d8-45c9-42fb-ad96-2f3ac60afc9c2025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackfe78b5b4-47bf-484b-ab37-e0d7de6fad572025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.e4508aa9-1e7a-4af7-829e-5fa353c92f5e2025-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDESUNRISE PHARMACEUTICAL, INC.a0439c85-5ede-4e02-aed2-47debd2c8eb22025-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacka1bca4b5-df64-4bac-a3a2-67f5c1eddbce2025-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HCL C-IVPHENTERMINE HCL C-IVDirect_Rxe4a2996e-2bfa-376f-e053-2995a90a0ed12025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
ndc (product): 72189-365
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDirectRxca683656-16a6-9602-e053-2a95a90aa8952025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackc8516abe-5ad1-4b76-8e2c-96ee455979cf2024-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackf427f067-f1a7-4d60-8ce0-90b20e2d4eb52024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackf50f5453-e06d-4e39-b868-9bdadf1d8baa2024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack3c37d637-779d-4097-85ef-e4ce7d0fb86a2024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack81751ece-8ccb-4aec-91ad-037c1d9fea532023-11-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEAsclemed USA, Inc.22683183-a828-47a4-9e52-38175d7c6f212023-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205019
application number: ANDA205019

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968766phentermine HCl 15 MG Oral CapsulePSNe4a2996e-2bfa-376f-e053-2995a90a0ed12
968766phentermine hydrochloride 15 MG Oral CapsuleSCDe4a2996e-2bfa-376f-e053-2995a90a0ed12
968766phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral CapsuleSYe4a2996e-2bfa-376f-e053-2995a90a0ed12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-365-307218903653030 CAPSULE in 1 BOTTLE (72189-365-30) 30 capsule2022-07-250000-00-00NoNoCurrent