Hycet

Product NDC
0713-0703
11-digit product format
007130703
Labeler code
0713
Product ID
0713-0703_3bb57616-ce87-5a68-17d7-8dc7f2963a1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone bitartrate and acetaminophen
Dosage form
SOLUTION
Route
ORAL
Labeler
G&W Laboratories, Inc.
Application
ANDA040482
Marketing category
ANDA
Marketing start
2011-02-01
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
8 mg/15mL; mg/15mL
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2019-12-31
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 1 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0713-0703-890efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0713-0703-89ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0713-0703-89367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0713-0703-89557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage0713-0703-898af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage0713-0703-89834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0713-0703-891332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0713-0703-89fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0713-0703-8986f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0713-0703-89bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0713-0703-898dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0713-0703-89e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0713-0703-899bebd1f3094a…5416666fcb17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE325MG/15ML;7.5MG/15MLSOLUTION / ORAL2003-09-25

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORAL2003-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORAL2003-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORAL2003-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORAL2003-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-253f01610625f2…
2019-09-15 20:21 UTC2019-09A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040482-001HYDROCODONE BITARTRATE AND ACETAMINOPHEN325MG/15ML;7.5MG/15MLSOLUTION / ORALAARS2003-09-25cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040482-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040482-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040482-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040482-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040482-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040482-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040482-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040482-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040482-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040482-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040482-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040482-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040482-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040482-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040482-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040482-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040482-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040482-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040482-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040482-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040482-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040482-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040482-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040482-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040482-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040482-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040482-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040482-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040482-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040482-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040482-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040482-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040482-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040482-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040482-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040482-001AA1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0713-0703-892020-01-31C16284748780-19d75b9d0-925c-f424-e053-dadaa90a57ceHycet ® CII hydrocodone bitartrate and acetaminophen oral solution 7.5 mg/325 mg per 15 mL Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0703-89ML - Milliliter0713-0703b0afc139-f480-4e64-b640-ff6afc769fd612014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DHYCET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [G&W LABORATORIES, INC.]4
Hydrocodone BitartrateACTIVE INGREDIENTNO70W886KKHYCET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [G&W LABORATORIES, INC.]4
AcetaminophenACTIVE MOIETY362O9ITL9DHYCET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [G&W LABORATORIES, INC.]4
HydrocodoneACTIVE MOIETY6YKS4Y3WQ7HYCET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [G&W LABORATORIES, INC.]4
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLHYCET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [G&W LABORATORIES, INC.]4
D&c Red No. 33INACTIVE INGREDIENT9DBA0SBB0LHYCET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [G&W LABORATORIES, INC.]4
Ethyl MaltolINACTIVE INGREDIENTL6Q8K29L05HYCET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [G&W LABORATORIES, INC.]4
Fd&c Red No. 40INACTIVE INGREDIENTWZB9127XOAHYCET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [G&W LABORATORIES, INC.]4
GlycerinINACTIVE INGREDIENTPDC6A3C0OXHYCET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [G&W LABORATORIES, INC.]4
MethylparabenINACTIVE INGREDIENTA2I8C7HI9THYCET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [G&W LABORATORIES, INC.]4
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3HYCET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [G&W LABORATORIES, INC.]4
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHHYCET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [G&W LABORATORIES, INC.]4
Saccharin Sodium DihydrateINACTIVE INGREDIENTSB8ZUX40TYHYCET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [G&W LABORATORIES, INC.]4
SorbitolINACTIVE INGREDIENT506T60A25RHYCET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [G&W LABORATORIES, INC.]4
SucroseINACTIVE INGREDIENTC151H8M554HYCET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [G&W LABORATORIES, INC.]4
WaterINACTIVE INGREDIENT059QF0KO0RHYCET (HYDROCODONE BITARTRATE AND ACETAMINOPHEN) SOLUTION [G&W LABORATORIES, INC.]4