Home NDC 40032-118-24 Hydrocodone Bitartrate and Homatropine Methylbromide
Product NDC 40032-118
Requested package NDC 40032-118-24
11-digit product format 400320118
Labeler code 40032
Product ID 40032-118_ced58732-29db-4f15-a4d4-858f3e4ecc4e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocodone Bitartrate and Homatropine Methylbromide
Dosage form TABLET
Route ORAL
Labeler Novel Laboratories, Inc.
Application ANDA091528
Marketing category ANDA
Marketing start 2014-09-23
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 2026-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091528-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL 2011-04-20
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A091528-001 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 1.5MG;5MG TABLET / ORAL 2011-04-20 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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 1.5 mg/1 HOMATROPINE METHYLBROMIDE 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 40032-118-03 Hydrocodone Bitartrate and Homatropine Methylbromide 30 in 1 BOTTLE TABLET 30 8 40032-118-24 Hydrocodone Bitartrate and Homatropine Methylbromide 100 in 1 BOTTLE TABLET 100 8 40032-118-26 Hydrocodone Bitartrate and Homatropine Methylbromide 500 in 1 BOTTLE TABLET 500 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HOMATROPINE METHYLBROMIDE ACTIVE INGREDIENT 68JRS2HC1C HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [NOVEL LABORATORIES, INC.] 1 HYDROCODONE BITARTRATE ACTIVE INGREDIENT NO70W886KK HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [NOVEL LABORATORIES, INC.] 1 HYDROCODONE ACTIVE MOIETY 6YKS4Y3WQ7 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [NOVEL LABORATORIES, INC.] 1 METHYLHOMATROPINE ACTIVE MOIETY P97OGJ7L1L HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [NOVEL LABORATORIES, INC.] 1 ANHYDROUS DIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT L11K75P92J HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [NOVEL LABORATORIES, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [NOVEL LABORATORIES, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [NOVEL LABORATORIES, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [NOVEL LABORATORIES, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [NOVEL LABORATORIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 40032-118 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLET [NOVEL LABORATORIES, INC.] 8 Current NDC, Legacy NDC, 3 package rows 20231213_b203c87c-1108-4eaa-8a57-87be776d8a70.zip
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 40032-118-24 40032011824 100 TABLET in 1 BOTTLE (40032-118-24) 100 tablet 2014-09-23 0000-00-00 No No Current