Phentermine Hydrochloride

Product NDC
71335-0350
11-digit product format
713350350
Labeler code
71335
Product ID
71335-0350_abbf6752-a400-4afe-9550-b4eb0ba7687c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040526
Marketing category
ANDA
Marketing start
2013-08-12
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040526-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040526-001AA

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-233f01610625f2…
2019-09-15 20:21 UTC2019-09A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040526-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2003-10-23cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040526-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040526-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040526-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040526-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040526-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040526-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040526-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040526-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040526-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040526-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040526-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040526-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040526-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040526-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040526-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040526-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040526-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040526-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040526-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040526-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040526-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040526-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040526-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040526-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040526-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040526-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040526-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040526-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040526-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040526-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040526-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040526-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040526-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040526-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040526-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040526-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040526-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040526-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040526-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040526-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Phentermine Hydrochloride
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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
53cad049-f1b4-42c0-9cc7-a1c2df75ac58Available 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
71335-0350-0Phentermine Hydrochloride90 in 1 BOTTLETABLET9011
71335-0350-1Phentermine Hydrochloride7 in 1 BOTTLETABLET711
71335-0350-2Phentermine Hydrochloride14 in 1 BOTTLETABLET1411
71335-0350-3Phentermine Hydrochloride15 in 1 BOTTLETABLET1511
71335-0350-4Phentermine Hydrochloride28 in 1 BOTTLETABLET2811
71335-0350-5Phentermine Hydrochloride30 in 1 BOTTLETABLET3011
71335-0350-6Phentermine Hydrochloride45 in 1 BOTTLETABLET4511
71335-0350-7Phentermine Hydrochloride60 in 1 BOTTLETABLET6011
71335-0350-8Phentermine Hydrochloride42 in 1 BOTTLETABLET4211
71335-0350-9Phentermine Hydrochloride56 in 1 BOTTLETABLET5611

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0350-0EA - Each71335-0350ba4c0897-4be8-4168-8db0-54b04beeca6412020-09-14
71335-0350-1EA - Each71335-0350b05614bb-af73-4f4d-b832-38a0d4f56c5c12018-05-09
71335-0350-2EA - Each71335-0350275e168a-69c7-4dc8-b56e-8f476e07230f12018-04-19
71335-0350-3EA - Each71335-0350babcffc4-2b81-4961-8ddd-a4210e1fcdf612018-05-09
71335-0350-4EA - Each71335-0350cb8f270f-6f92-4ba5-8fc7-1642dafa97ee12018-05-09
71335-0350-5EA - Each71335-03507a994341-202a-474f-a742-687452e7da6b12018-04-19
71335-0350-6EA - Each71335-0350632c61cf-9927-4fd2-ab9f-7f9ac1214b8f12018-04-19
71335-0350-7EA - Each71335-03503bbdd6c4-4a6a-42ad-8c65-a71fa154b0e912020-09-14
71335-0350-9EA - Each71335-0350d045dda0-53e3-4c84-ad6f-9e19d5beaf3112020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0350PHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 10 package rows20240822_53cad049-f1b4-42c0-9cc7-a1c2df75ac58.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HCL C-IVPHENTERMINE HCL C-IVDirect_Rx4cec0e47-5373-2133-e063-6394a90a20092026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.aa9d7161-cda3-4ded-8d5b-424abd1a66812026-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEA-S Medication Solutions0e893b62-bb07-4984-9f0a-3601435fbc272026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENorthwind Health Company, LLC1b5396a8-e7ef-45ae-e063-6294a90a14a22025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.abf702d6-6f94-48dc-ad23-c52fd74e83a82025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEMartek Pharmacal Co.12699287-9ca9-07b3-e063-6294a90af21a2025-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.02b8f684-b1ca-4ab7-9567-bcacc6a927792025-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.312d9742-6a65-c1cb-e063-6394a90a2e662025-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8abf898e-318b-3519-e053-2995a90abf2f2024-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack53cad049-f1b4-42c0-9cc7-a1c2df75ac582024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
ndc (product): 71335-0350
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack0ca26b58-0a93-4a10-be4d-63a4ad5eecf82024-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackac8559a0-98fe-4737-b9ec-e36eef3b14fc2024-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackc5d60a6d-2410-4a3c-88e1-a6126b56cf6a2024-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack95f908c2-1003-4e8f-8e4a-86f4934568782024-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack83802088-f4fc-4b34-9268-d63fb2ad16552023-09-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEProficient Rx LPb14a8f6a-a1c6-4104-80f2-0fa35320d04c2023-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040526
application number: ANDA040526

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0350-07133503500090 TABLET in 1 BOTTLE (71335-0350-0) 90 tablet2018-11-200000-00-00NoNoCurrent
71335-0350-1713350350017 TABLET in 1 BOTTLE (71335-0350-1) 7 tablet2018-04-100000-00-00NoNoCurrent
71335-0350-27133503500214 TABLET in 1 BOTTLE (71335-0350-2) 14 tablet2018-03-120000-00-00NoNoCurrent
71335-0350-37133503500315 TABLET in 1 BOTTLE (71335-0350-3) 15 tablet2018-03-200000-00-00NoNoCurrent
71335-0350-47133503500428 TABLET in 1 BOTTLE (71335-0350-4) 28 tablet2018-04-020000-00-00NoNoCurrent
71335-0350-57133503500530 TABLET in 1 BOTTLE (71335-0350-5) 30 tablet2018-03-270000-00-00NoNoCurrent
71335-0350-67133503500645 TABLET in 1 BOTTLE (71335-0350-6) 45 tablet2018-03-130000-00-00NoNoCurrent
71335-0350-77133503500760 TABLET in 1 BOTTLE (71335-0350-7) 60 tablet2018-04-060000-00-00NoNoCurrent
71335-0350-87133503500842 TABLET in 1 BOTTLE (71335-0350-8) 42 tablet2018-04-090000-00-00NoNoCurrent
71335-0350-97133503500956 TABLET in 1 BOTTLE (71335-0350-9) 56 tablet2018-03-260000-00-00NoNoCurrent