Phentermine Hydrochloride

Product NDC
63187-144
11-digit product format
631870144
Labeler code
63187
Product ID
63187-144_355f5170-b129-4ac9-be61-ea70b04c4ee5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phentermine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040526
Marketing category
ANDA
Marketing start
2013-08-12
Marketing end
0000-00-00
Substance
PHENTERMINE HYDROCHLORIDE
Active strength
38 mg/1
Pharmacologic classes
Appetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63187-144DDiscontinued by firm2026-08-03
excluded packagepackage63187-14463187-144-30DDiscontinued by firm2026-08-03

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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-144-30DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-144-30DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63187-144-30DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63187-144-30DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63187-144-30DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63187-144-30DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63187-144-30DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63187-144-30DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63187-144-30DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63187-144-30DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63187-144-30DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63187-144-30DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63187-144-30IInactivated by FDA110d247fa046…a55b01930146…

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…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phentermine HydrochlorideACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
PhentermineACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
calcium phosphate, dibasic, dihydrateINACTIVE INGREDIENTO7TSZ97GEPPHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
crospovidoneINACTIVE INGREDIENT68401960MKPHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1
povidonesINACTIVE INGREDIENTFZ989GH94EPHENTERMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1

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
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