Home NDC 40032-810 Hydrocodone Bitartrate and Homatropine Methylbromide
Product NDC 40032-810
11-digit product format 400320810
Labeler code 40032
Product ID 40032-810_c524711b-29fd-41d1-b026-072e7314b06a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocodone Bitartrate and Homatropine Methylbromide
Dosage form SYRUP
Route ORAL
Labeler Novel Laboratories, Inc.
Application ANDA203535
Marketing category ANDA
Marketing start 2017-02-13
Substance HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE
Active strength 5; 1.5 mg/5mL; mg/5mL
Pharmacologic classes Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule CII
NDC exclude flag No
Listing certified through 2026-12-31
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 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203535-001 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 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203535-001 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE 1.5MG/5ML;5MG/5ML SYRUP / ORAL AA 2017-02-13 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 2026-12-31 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 40032-810-05 Hydrocodone Bitartrate and Homatropine Methylbromide 473 mL in 1 BOTTLE SYRUP 473 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 40032-810 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SYRUP [NOVEL LABORATORIES, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20241204_4050ae05-7f1a-48b7-99b9-f8db8aa02741.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 40032-810-05 40032081005 473 mL in 1 BOTTLE (40032-810-05) 473 ml 2017-02-13 0000-00-00 Yes No Current