Methamphetamine Hydrochloride

Product NDC
75907-094
11-digit product format
759070094
Labeler code
75907
Product ID
75907-094_c77198dd-fd98-ac84-9754-517e77c5c729
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHAMPHETAMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA091189
Marketing category
ANDA
Marketing start
2025-11-07
Substance
METHAMPHETAMINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Amphetamine Anorectic [EPC], Amphetamines [CS], Appetite Suppression [PE], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A091189-001METHAMPHETAMINE HYDROCHLORIDEMETHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091189-001AA

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 UTC2026-02A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-213f01610625f2…
2019-09-15 20:21 UTC2019-09A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091189-001METHAMPHETAMINE HYDROCHLORIDE5MGTABLET / ORALAA2010-04-21cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091189-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091189-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091189-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091189-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091189-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091189-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091189-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091189-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091189-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091189-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091189-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091189-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091189-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091189-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091189-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091189-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091189-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091189-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091189-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091189-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091189-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A091189-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091189-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091189-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091189-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A091189-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091189-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091189-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091189-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091189-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091189-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091189-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091189-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091189-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091189-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091189-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091189-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091189-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091189-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091189-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Methamphetamine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHAMPHETAMINE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
997F43Z9CVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
977860Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d0905e2c-a02f-ec4f-59a3-6f7ad0acbbf6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5440a9f9-c375-37ca-695e-afb814e3df29Product name220151120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75907-094-01Methamphetamine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75907-094-01EA - Each75907-09483b45ac0-4141-48eb-821f-9f4759a71d8812026-03-17

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methamphetamine HydrochlorideMETHAMPHETAMINE HYDROCHLORIDEDr. Reddy's Laboratories Incd0905e2c-a02f-ec4f-59a3-6f7ad0acbbf62025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091189
application number: ANDA091189
ndc (product): 75907-094
Methamphetamine HydrochlorideMETHAMPHETAMINE HYDROCHLORIDEMayne Pharma Commercial LLCf31f580f-1f08-4a0f-b078-0b9e3308f7122023-07-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091189
application number: ANDA091189

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977860methamphetamine HCl 5 MG Oral TabletPSNd0905e2c-a02f-ec4f-59a3-6f7ad0acbbf62
977860methamphetamine hydrochloride 5 MG Oral TabletSCDd0905e2c-a02f-ec4f-59a3-6f7ad0acbbf62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75907-094-0175907009401100 TABLET in 1 BOTTLE, PLASTIC (75907-094-01) 100 tablet2025-11-07NoNoCurrent