Home NDC 64850-630 Hydrocodone Bitartrate and Acetaminophen
Product NDC 64850-630
11-digit product format 648500630
Labeler code 64850
Product ID 64850-630_91acad07-a9ce-450e-b9f6-4401b89bd32c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocodone Bitartrate and Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Elite Laboratories, Inc.
Application ANDA209924
Marketing category ANDA
Marketing start 2018-11-16
Substance ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength 325; 2.5 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 64850-630-90 excluded package package 64850-630-30 excluded package package 64850-630-60
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209924-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;2.5MG TABLET / ORAL AA 2018-11-16 A209924-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;5MG TABLET / ORAL AA 2018-11-16 A209924-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;7.5MG TABLET / ORAL AA 2018-11-16 A209924-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET / ORAL AA 2018-11-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 5 · 172 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 A209924-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2018-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209924-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209924-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209924-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-11-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209924-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2018-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209924-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209924-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209924-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-11-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209924-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2018-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209924-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209924-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209924-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209924-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2018-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209924-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209924-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209924-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209924-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2018-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209924-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209924-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209924-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209924-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2018-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209924-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209924-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209924-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209924-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2018-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209924-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209924-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209924-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209924-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2018-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209924-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209924-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209924-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209924-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL AA 2018-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209924-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL AA 2018-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209924-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL AA 2018-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209924-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2018-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209924-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;2.5MG TABLET / ORAL 2018-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209924-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;5MG TABLET / ORAL 2018-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209924-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;7.5MG TABLET / ORAL 2018-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209924-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2018-11-16 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCODONE BITARTRATE 2.5 mg/1 ACETAMINOPHEN 325 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 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 856999 Internal RxNorm lookup 857002 Internal RxNorm lookup 857005 Internal RxNorm lookup 857391 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 64850-630-01 Hydrocodone Bitartrate and Acetaminophen 100 in 1 BOTTLE, PLASTIC TABLET 100 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64850-630 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [ELITE LABORATORIES, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20240831_89b8145f-5310-4b58-a65d-586dc90d642d.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 Sample Exclude flag Status 64850-630-01 64850063001 100 TABLET in 1 BOTTLE, PLASTIC (64850-630-01) 100 tablet 2018-11-16 No No Current