Home NDC 64950-343 Hydrocodone Bitartrate and Acetaminophen
Product NDC 64950-343
11-digit product format 649500343
Labeler code 64950
Product ID 64950-343_9ec83613-4c13-4ab7-a71d-c100d30c1e30
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydrocodone bitartrate and acetaminophen
Dosage form SOLUTION
Route ORAL
Labeler Genus Lifesciences Inc.
Application ANDA040894
Marketing category ANDA
Marketing start 2020-06-20
Substance ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength 325; 7.5 mg/15mL; mg/15mL
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 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040894-001 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 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040894-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG/15ML;7.5MG/15ML SOLUTION / ORAL AA 2011-07-19 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 Acetaminophen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCODONE BITARTRATE 7.5 mg/15mL ACETAMINOPHEN 325 mg/15mL
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 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 856940 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 64950-343-11 Hydrocodone Bitartrate and Acetaminophen 118 mL in 1 BOTTLE SOLUTION 118 5 64950-343-16 Hydrocodone Bitartrate and Acetaminophen 473 mL in 1 BOTTLE SOLUTION 473 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64950-343 HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [GENUS LIFESCIENCES INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240823_26242cd7-1dbe-4ca4-88ca-5b98a6566ff9.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 64950-343-11 64950034311 118 mL in 1 BOTTLE (64950-343-11) 118 ml 2020-06-20 No No Current 64950-343-16 64950034316 473 mL in 1 BOTTLE (64950-343-16) 473 ml 2020-06-20 0000-00-00 No No Current