FDA.reportPublic FDA data

Hydrocodone Bitartrate and Homatropine Methylbromide

Product NDC
17856-0043
11-digit product format
178560043
Labeler code
17856
Product ID
17856-0043_19078c90-5ea1-4bcf-bc45-48a98be6f698
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Homatropine Methylbromide
Dosage form
SYRUP
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA040613
Marketing category
ANDA
Marketing start
2008-02-08
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct17856-0043IInactivated by FDA2026-07-31
excluded packagepackage17856-004317856-0043-1IInactivated by FDA2026-07-31

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
A040613-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEHOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE1.5MG/5ML;5MG/5MLSYRUP / ORAL2008-02-08

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040613-001HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE1.5MG/5ML;5MG/5MLSYRUP / ORAL2008-02-08a50c72e98297…

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
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
17856-0043-12020-01-31C16284748780-19d75b9d0-15e5-f424-e053-dadaa90a57ceHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0043-1Hydrocodone Bitartrate and Homatropine Methylbromide5 mL in 1 CUP, UNIT-DOSESYRUP52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0043HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]2Legacy NDC, 1 package rows20160629_0f06291e-6329-4eb0-8cb7-80a14111d480.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 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-0043-1178560043015 mL in 1 CUP, UNIT-DOSE5 mlHistorical