Methadone Hydrochloride

Product NDC
71335-0493
11-digit product format
713350493
Labeler code
71335
Product ID
71335-0493_cc79daec-2430-4d17-a37d-5a7ff5bfd883
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methadone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203502
Marketing category
ANDA
Marketing start
2015-09-15
Marketing end
0000-00-00
Substance
METHADONE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-0493DDiscontinued by firm2026-08-17
excluded packagepackage71335-049371335-0493-1DDiscontinued by firm2026-08-17
excluded packagepackage71335-049371335-0493-2DDiscontinued by firm2026-08-17
excluded packagepackage71335-049371335-0493-3DDiscontinued by firm2026-08-17
excluded packagepackage71335-049371335-0493-4DDiscontinued by firm2026-08-17
excluded packagepackage71335-049371335-0493-5DDiscontinued by firm2026-08-17
excluded packagepackage71335-049371335-0493-6DDiscontinued by firm2026-08-17
excluded packagepackage71335-049371335-0493-7DDiscontinued by firm2026-08-17

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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-0493-7557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-0493-5557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-0493-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-0493-6557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-0493-4557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-0493-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-0493-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-0493-78af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-0493-58af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-0493-38af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-0493-68af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-0493-48af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-0493-28af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-0493-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-0493-7834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-0493-5834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-0493-3834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-0493-6834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-0493-4834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-0493-2834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-0493-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-0493-71332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-0493-51332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-0493-31332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-0493-61332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-0493-41332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-0493-21332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-0493-11332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203502-001METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-31
A203502-002METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203502-001AA
A203502-002AA

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-31caaa826d4ba7…
2026-08-18 06:07:402026-07A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203502-001METHADONE HYDROCHLORIDE5MGTABLET / ORALAA2015-08-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203502-002METHADONE HYDROCHLORIDE10MGTABLET / ORALAA2015-08-31bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203502-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A203502-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203502-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203502-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203502-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203502-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203502-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203502-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203502-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203502-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203502-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203502-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203502-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203502-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203502-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203502-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203502-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203502-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203502-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203502-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203502-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203502-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203502-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203502-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203502-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203502-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203502-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203502-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203502-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203502-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203502-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203502-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203502-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203502-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203502-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203502-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203502-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203502-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203502-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203502-002AA1bb7c543d1eb4…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71335-0493-12024-08-20These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947
71335-0493-22024-08-20These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947
71335-0493-32024-08-20These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947
71335-0493-42024-08-20These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947
71335-0493-52024-08-20These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947
71335-0493-62024-08-20These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947
71335-0493-72024-08-20These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947
71335-0493-12024-01-30These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947
71335-0493-22024-01-30These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947
71335-0493-32024-01-30These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947
71335-0493-42024-01-30These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947
71335-0493-52024-01-30These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947
71335-0493-62024-01-30These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947
71335-0493-72024-01-30These highlights do not include all the information needed to use Methadone Hydrochloride Tablets, USP safely and effectively. See full prescribing information for Methadone Hydrochloride Tablets, USP. Methadone Hydrochloride Tablets, USP, for oral use CII Initial U.S. Approval: 1947

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0493-1EA - Each71335-0493e540cb02-85f8-422d-9a5e-d20560d0ebfe12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0493METHADONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]8Legacy NDC20240822_cc79daec-2430-4d17-a37d-5a7ff5bfd883.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methadone HydrochlorideMETHADONE HYDROCHLORIDEAurolife Pharma, LLC6984eb5a-57a3-4686-bc67-91bc3e7a531e2025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203502
application number: ANDA203502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0493-17133504930190 TABLET in 1 BOTTLE (71335-0493-1) 90 tablet2017-07-180000-00-00NoNoCurrent
71335-0493-27133504930230 TABLET in 1 BOTTLE (71335-0493-2) 30 tablet2017-07-180000-00-00NoNoCurrent
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