Hydrocodone Bitartrate and Homatropine Methylbromide

Product NDC
10702-055
11-digit product format
107020055
Labeler code
10702
Product ID
10702-055_47ba86ad-2410-e733-e063-6394a90a24e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Homatropine Methylbromide
Dosage form
TABLET
Route
ORAL
Labeler
KVK-Tech, Inc.
Application
ANDA207176
Marketing category
ANDA
Marketing start
2017-08-07
Substance
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
Active strength
1.5; 5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATEHOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207176-001AA

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAA2017-08-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAA2017-08-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAA2017-08-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAA2017-08-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAA2017-08-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAA2017-08-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAA2017-08-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAA2017-08-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAA2017-08-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAA2017-08-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAA2017-08-073f01610625f2…
2019-09-15 20:21 UTC2019-09A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAA2017-08-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAA2017-08-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAARS2017-08-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAA2017-08-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAA2017-08-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207176-001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE1.5MG;5MGTABLET / ORALAA2017-08-07e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207176-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207176-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207176-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207176-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207176-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207176-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207176-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207176-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207176-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207176-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207176-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207176-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207176-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207176-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207176-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207176-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207176-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207176-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207176-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207176-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207176-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207176-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A207176-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207176-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207176-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207176-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A207176-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207176-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207176-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207176-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207176-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207176-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207176-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207176-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207176-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207176-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207176-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207176-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207176-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207176-001AA1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocodone Bitartrate and Homatropine Methylbromide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCODONE BITARTRATE5 mg/1
HOMATROPINE METHYLBROMIDE1.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NO70W886KKInternal UNII lookup
68JRS2HC1CInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
26d7c90c-5e6b-4bdb-b06f-c76173a01c21Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-055-01Hydrocodone Bitartrate and Homatropine Methylbromide100 in 1 BOTTLETABLET1009
10702-055-03Hydrocodone Bitartrate and Homatropine Methylbromide30 in 1 BOTTLETABLET309
10702-055-09Hydrocodone Bitartrate and Homatropine Methylbromide90 in 1 BOTTLETABLET909
10702-055-10Hydrocodone Bitartrate and Homatropine Methylbromide1000 in 1 BOTTLETABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-055-01EA - Each10702-055d80f73e2-22f0-497e-9c25-c2c913b4001012017-10-13
10702-055-03EA - Each10702-0555477b5a7-66b9-44f4-a5d1-d7f9da7b619112017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-055HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [KVK-TECH, INC.]8Current NDC, Legacy NDC, 4 package rows20181220_26d7c90c-5e6b-4bdb-b06f-c76173a01c21.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and Homatropine MethylbromideHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEKVK-Tech, Inc.26d7c90c-5e6b-4bdb-b06f-c76173a01c212026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207176
application number: ANDA207176
ndc (product): 10702-055

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992656HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG Oral TabletPSN26d7c90c-5e6b-4bdb-b06f-c76173a01c219
992656homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG Oral TabletSCD26d7c90c-5e6b-4bdb-b06f-c76173a01c219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-055-0110702005501100 TABLET in 1 BOTTLE (10702-055-01) 100 tablet2017-08-070000-00-00NoNoCurrent
10702-055-031070200550330 TABLET in 1 BOTTLE (10702-055-03) 30 tablet2017-08-070000-00-00NoNoCurrent
10702-055-091070200550990 TABLET in 1 BOTTLE (10702-055-09) 90 tablet2017-08-070000-00-00NoNoCurrent
10702-055-10107020055101000 TABLET in 1 BOTTLE (10702-055-10) 1000 tablet2017-08-070000-00-00NoNoCurrent