Methamphetamine Hydrochloride

Product NDC: 68308-115
Requested package NDC: 68308-115-01
11-digit product format: 683080115
Labeler code: 68308
Product ID: 68308-115_ffc2cd39-e42b-5821-e053-6394a90a9974
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METHAMPHETAMINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Mayne Pharma Commercial LLC
Application: ANDA091189
Marketing category: ANDA
Marketing start: 2010-04-26
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091189-001	METHAMPHETAMINE HYDROCHLORIDE	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA		2010-04-21

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091189-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-04-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091189-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091189-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091189-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091189-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091189-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091189-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091189-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091189-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091189-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091189-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091189-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091189-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091189-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091189-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091189-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091189-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091189-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091189-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091189-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091189-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091189-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091189-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091189-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091189-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091189-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091189-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091189-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091189-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091189-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091189-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091189-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091189-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091189-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091189-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091189-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091189-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091189-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091189-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091189-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091189-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHAMPHETAMINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
997F43Z9CV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f31f580f-1f08-4a0f-b078-0b9e3308f712	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5440a9f9-c375-37ca-695e-afb814e3df29	Product name	2	20151120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68308-115-01	Methamphetamine Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET	100		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68308-115-01	EA - Each	68308-115	9e6e9717-56de-4524-adab-715f0a3321b5	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHAMPHETAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	997F43Z9CV	METHAMPHETAMINE HYDROCHLORIDE TABLET [MAYNE PHARMA]	2
Methamphetamine	ACTIVE MOIETY	44RAL3456C	METHAMPHETAMINE HYDROCHLORIDE TABLET [MAYNE PHARMA]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	METHAMPHETAMINE HYDROCHLORIDE TABLET [MAYNE PHARMA]	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	METHAMPHETAMINE HYDROCHLORIDE TABLET [MAYNE PHARMA]	2
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	METHAMPHETAMINE HYDROCHLORIDE TABLET [MAYNE PHARMA]	2
talc	INACTIVE INGREDIENT	7SEV7J4R1U	METHAMPHETAMINE HYDROCHLORIDE TABLET [MAYNE PHARMA]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68308-115	METHAMPHETAMINE HYDROCHLORIDE TABLET [MAYNE PHARMA COMMERCIAL LLC]	11	Current NDC, Legacy NDC, 1 package rows	20230707_f31f580f-1f08-4a0f-b078-0b9e3308f712.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methamphetamine Hydrochloride	METHAMPHETAMINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc	d0905e2c-a02f-ec4f-59a3-6f7ad0acbbf6	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091189 application number: ANDA091189
Methamphetamine Hydrochloride	METHAMPHETAMINE HYDROCHLORIDE	Mayne Pharma Commercial LLC	f31f580f-1f08-4a0f-b078-0b9e3308f712	2023-07-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091189 application number: ANDA091189 ndc (package): 68308-115-01 ndc (product): 68308-115 ndc11 (package): 68308011501

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
997F43Z9CV	METHAMPHETAMINE HYDROCHLORIDE	51-57-0	METHAMPHETAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
977860	methamphetamine HCl 5 MG Oral Tablet	PSN	f31f580f-1f08-4a0f-b078-0b9e3308f712	11
977860	methamphetamine hydrochloride 5 MG Oral Tablet	SCD	f31f580f-1f08-4a0f-b078-0b9e3308f712	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68308-115-01	68308011501	100 TABLET in 1 BOTTLE, PLASTIC (68308-115-01)	100 tablet	2010-04-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methamphetamine Hydrochloride Tablets, USP	Mayne Pharma Commercial LLC \| Catalent Greenville, Inc.	2023-07-05	HUMAN PRESCRIPTION DRUG LABEL	11