Home NDC 66336-444 Hydrocodone Bitartrate And Acetaminophen
Product NDC 66336-444
11-digit product format 663360444
Labeler code 66336
Product ID 66336-444_90381683-704b-410f-91ad-1a5c41fcf657
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocodone Bitartrate And Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Dispensing Solutions, Inc.
Application ANDA040355
Marketing category ANDA
Marketing start 2000-05-31
Marketing end 0000-00-00
Substance HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength 10 mg/1; mg/1
Pharmacologic classes Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule CIII
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record
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 5 · 264 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG TABLET / ORAL 2000-05-31
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 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2000-05-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2000-05-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL 2000-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040355-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN 325MG;10MG TABLET / ORAL AA 2000-05-31 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 66336-444-10 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only 66336-444-12 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only 66336-444-20 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only 66336-444-21 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only 66336-444-30 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only 66336-444-55 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only 66336-444-58 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only 66336-444-60 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only 66336-444-62 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only 66336-444-90 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only 66336-444-94 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66336-444-10 Hydrocodone Bitartrate And Acetaminophen 10 in 1 BOTTLE, PLASTIC TABLET 10 3 66336-444-12 Hydrocodone Bitartrate And Acetaminophen 12 in 1 BOTTLE, PLASTIC TABLET 12 3 66336-444-20 Hydrocodone Bitartrate And Acetaminophen 20 in 1 BOTTLE, PLASTIC TABLET 20 3 66336-444-21 Hydrocodone Bitartrate And Acetaminophen 21 in 1 BOTTLE, PLASTIC TABLET 21 3 66336-444-30 Hydrocodone Bitartrate And Acetaminophen 30 in 1 BOTTLE, PLASTIC TABLET 30 3 66336-444-55 Hydrocodone Bitartrate And Acetaminophen 150 in 1 BOTTLE, PLASTIC TABLET 150 3 66336-444-58 Hydrocodone Bitartrate And Acetaminophen 140 in 1 BOTTLE, PLASTIC TABLET 140 3 66336-444-60 Hydrocodone Bitartrate And Acetaminophen 60 in 1 BOTTLE, PLASTIC TABLET 60 3 66336-444-62 Hydrocodone Bitartrate And Acetaminophen 180 in 1 BOTTLE, PLASTIC TABLET 180 3 66336-444-90 Hydrocodone Bitartrate And Acetaminophen 90 in 1 BOTTLE, PLASTIC TABLET 90 3 66336-444-94 Hydrocodone Bitartrate And Acetaminophen 120 in 1 BOTTLE, PLASTIC TABLET 120 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.] 3 HYDROCODONE BITARTRATE ACTIVE INGREDIENT NO70W886KK HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.] 3 HYDROCODONE ACTIVE MOIETY 6YKS4Y3WQ7 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.] 3 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.] 3 POVIDONE INACTIVE INGREDIENT FZ989GH94E HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.] 3 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66336-444 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DISPENSING SOLUTIONS, INC.] 3 Legacy NDC, 11 package rows 20130709_930b3a2b-b79d-4290-b358-bd1bb214c96b.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 66336-444-10 66336044410 10 in 1 BOTTLE, PLASTIC Historical 66336-444-12 66336044412 12 in 1 BOTTLE, PLASTIC Historical 66336-444-20 66336044420 20 in 1 BOTTLE, PLASTIC Historical 66336-444-21 66336044421 21 in 1 BOTTLE, PLASTIC Historical 66336-444-30 66336044430 30 in 1 BOTTLE, PLASTIC Historical 66336-444-55 66336044455 150 in 1 BOTTLE, PLASTIC Historical 66336-444-58 66336044458 140 in 1 BOTTLE, PLASTIC Historical 66336-444-60 66336044460 60 in 1 BOTTLE, PLASTIC Historical 66336-444-62 66336044462 180 in 1 BOTTLE, PLASTIC Historical 66336-444-90 66336044490 90 in 1 BOTTLE, PLASTIC Historical 66336-444-94 66336044494 120 in 1 BOTTLE, PLASTIC Historical