FDA.reportPublic FDA data

Hydrocodone Bitartrate and Homatropine Methylbromide

Product NDC
50383-043
11-digit product format
503830043
Labeler code
50383
Product ID
50383-043_de69b3f3-56b3-4392-998c-1b0352a2fdc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Homatropine Methylbromide
Dosage form
SOLUTION
Route
ORAL
Labeler
Akorn
Application
ANDA040613
Marketing category
ANDA
Marketing start
2008-02-08
Marketing end
0000-00-00
Substance
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
Active strength
2 mg/5mL; mg/5mL
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-043-162024-01-30C16284748780-11030e365-13c6-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION. HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE oral solution, CII Initial U.S. Approval: 1943

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-043-16Hydrocodone Bitartrate and Homatropine Methylbromide473 mL in 1 BOTTLESOLUTION47321

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-043-16ML - Milliliter50383-0434f4f451e-ebcc-463f-bbde-047a12e553c712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HOMATROPINE METHYLBROMIDEACTIVE INGREDIENT68JRS2HC1CHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]9
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]9
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]9
METHYLHOMATROPINEACTIVE MOIETYP97OGJ7L1LHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]9
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]9
CARAMELINACTIVE INGREDIENTT9D99G2B1RHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]9
CHERRYINACTIVE INGREDIENTBUC5I9595WHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]9
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]9
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]9
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]9
SORBITOLINACTIVE INGREDIENT506T60A25RHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]9
SUCROSEINACTIVE INGREDIENTC151H8M554HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]9
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [HI-TECH PHARMACAL CO., INC.]9
HOMATROPINE METHYLBROMIDEACTIVE INGREDIENT68JRS2HC1CHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]3
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]3
HOMATROPINEACTIVE MOIETY8QS6WCL55ZHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]3
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]3
HOMATROPINE METHYLBROMIDEACTIVE INGREDIENT68JRS2HC1CHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
HOMATROPINEACTIVE MOIETY8QS6WCL55ZHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
CARAMELINACTIVE INGREDIENTT9D99G2B1RHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
CHERRYINACTIVE INGREDIENTBUC5I9595WHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
SORBITOLINACTIVE INGREDIENT506T60A25RHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-043HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SOLUTION [AKORN]21Legacy NDC, 1 package rows20220312_7d45e534-338b-4c98-b85f-edd19a287e14.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 SolutionPSN7d45e534-338b-4c98-b85f-edd19a287e1421
992668homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral SolutionSCD7d45e534-338b-4c98-b85f-edd19a287e1421
992668homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML SyrupSY7d45e534-338b-4c98-b85f-edd19a287e1421
992668HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral SolutionPSN0184de92-e728-4390-95f6-a463f583416a3
992668homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral SolutionSCD0184de92-e728-4390-95f6-a463f583416a3
992668homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML SyrupSY0184de92-e728-4390-95f6-a463f583416a3
992668HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral SolutionPSN0f06291e-6329-4eb0-8cb7-80a14111d4802
992668homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral SolutionSCD0f06291e-6329-4eb0-8cb7-80a14111d4802
992668homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML SyrupSY0f06291e-6329-4eb0-8cb7-80a14111d4802
992668HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral SolutionPSN95828fad-323e-4510-acbf-6d354b25b8871
992668homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral SolutionSCD95828fad-323e-4510-acbf-6d354b25b8871
992668homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML SyrupSY95828fad-323e-4510-acbf-6d354b25b8871

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-043-1650383004316473 mL in 1 BOTTLE (50383-043-16) 473 ml2008-02-080000-00-00NoNoCurrent