Home NDC 10702-150 Hydrocodone Bitartrate and Homatropine Methylbromide
Product NDC 10702-150
11-digit product format 107020150
Labeler code 10702
Product ID 10702-150_526d7f1f-bdeb-5e1f-e063-6294a90a6916
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydrocodone bitartrate and homatropine methylbromide oral solution
Dosage form LIQUID
Route ORAL
Labeler KVK-Tech, Inc.
Application ANDA207487
Marketing category ANDA
Marketing start 2017-02-21
Substance HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
Active strength 1.5; 5 mg/5mL; mg/5mL
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA RS 2017-02-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207487-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA RS 2017-02-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA RS 2017-02-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA RS 2017-02-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA RS 2017-02-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA RS 2017-02-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA RS 2017-02-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA RS 2017-02-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA RS 2017-02-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA RS 2017-02-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA RS 2017-02-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA RS 2017-02-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA RS 2017-02-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA RS 2017-02-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA RS 2017-02-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA RS 2017-02-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207487-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-21 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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/5mL HOMATROPINE METHYLBROMIDE 1.5 mg/5mL
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 992668 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 10702-150-16 Hydrocodone Bitartrate and Homatropine Methylbromide 473 mL in 1 BOTTLE LIQUID 473 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10702-150 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION) LIQUID [KVK-TECH, INC.] 11 Current NDC, Legacy NDC, 1 package rows 20181220_9a737416-08e0-4df6-897e-cf9d1b5f0b01.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 10702-150-16 10702015016 473 mL in 1 BOTTLE (10702-150-16) 473 ml 2017-02-21 0000-00-00 No No Current