Home NDC 10702-055 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 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207176-001 AA
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA 2017-08-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA 2017-08-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA 2017-08-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA 2017-08-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA 2017-08-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA 2017-08-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA 2017-08-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA 2017-08-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA 2017-08-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA 2017-08-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA 2017-08-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA 2017-08-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA 2017-08-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA RS 2017-08-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA 2017-08-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207176-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL AA 2017-08-07 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Hydrocodone Bitartrate and Homatropine Methylbromide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCODONE BITARTRATE 5 mg/1 HOMATROPINE METHYLBROMIDE 1.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination NO70W886KK Internal UNII lookup 68JRS2HC1C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 992656 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10702-055-01 Hydrocodone Bitartrate and Homatropine Methylbromide 100 in 1 BOTTLE TABLET 100 9 10702-055-03 Hydrocodone Bitartrate and Homatropine Methylbromide 30 in 1 BOTTLE TABLET 30 9 10702-055-09 Hydrocodone Bitartrate and Homatropine Methylbromide 90 in 1 BOTTLE TABLET 90 9 10702-055-10 Hydrocodone Bitartrate and Homatropine Methylbromide 1000 in 1 BOTTLE TABLET 1000 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10702-055 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [KVK-TECH, INC.] 8 Current NDC, Legacy NDC, 4 package rows 20181220_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10702-055-01 10702005501 100 TABLET in 1 BOTTLE (10702-055-01) 100 tablet 2017-08-07 0000-00-00 No No Current 10702-055-03 10702005503 30 TABLET in 1 BOTTLE (10702-055-03) 30 tablet 2017-08-07 0000-00-00 No No Current 10702-055-09 10702005509 90 TABLET in 1 BOTTLE (10702-055-09) 90 tablet 2017-08-07 0000-00-00 No No Current 10702-055-10 10702005510 1000 TABLET in 1 BOTTLE (10702-055-10) 1000 tablet 2017-08-07 0000-00-00 No No Current