HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

Product NDC
59741-262
11-digit product format
597410262
Labeler code
59741
Product ID
59741-262_7f96db16-608e-1f00-e053-2a91aa0aca5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Bio-Pharm, Inc.
Application
ANDA204765
Marketing category
ANDA
Marketing start
2017-03-07
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE
Active strength
5 mg/5mL; mg/5mL
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59741-262IInactivated by FDA2026-10-05
excluded packagepackage59741-26259741-262-16IInactivated by FDA2026-10-05

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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59741-262-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59741-262-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59741-262-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59741-262-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59741-262-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59741-262-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59741-262-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59741-262-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59741-262-160efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59741-262-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59741-262-16367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59741-262-16557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage59741-262-168af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage59741-262-16834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage59741-262-161332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage59741-262-16fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage59741-262-1686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage59741-262-16bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage59741-262-168dfbde2a14a4…c9ff85d89658…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEHOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-06

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-0684e616aacf4f…
2026-08-18 06:07:402026-07A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORALAA2017-03-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-063f01610625f2…
2019-09-15 20:21 UTC2019-09A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORALAA2017-03-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORALAA2017-03-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204765-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2017-03-06f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A204765-001AA174a2ff9319b5…
2019-09-15 20:21 UTC2019-09A204765-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204765-001AA1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7855f8e3-562e-4273-8b79-0059c07a71f7Product name120170901
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
a5244f9c-cd67-0e27-d63b-65fd7e584400Product name220170504
b654f2d9-ebeb-451d-96ee-22f583344623Product name120170424
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59741-262-16HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE473 mL in 1 BOTTLESOLUTION4738

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59741-262-16ML - Milliliter59741-262a4030e54-2aaa-445a-b1bf-a137efb5699612018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59741-262HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SOLUTION [BIO-PHARM, INC.]8Legacy NDC, 1 package rows20190117_8d4a9c18-f9e8-4474-8c76-7378bcdcacb6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992668HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral SolutionPSN8d4a9c18-f9e8-4474-8c76-7378bcdcacb68
992668homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral SolutionSCD8d4a9c18-f9e8-4474-8c76-7378bcdcacb68
992668homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML SyrupSY8d4a9c18-f9e8-4474-8c76-7378bcdcacb68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
59741-262-1659741026216473 mL in 1 BOTTLE473 mlHistorical