Methamphetamine Hydrochloride

Product NDC: 0054-0389
11-digit product format: 000540389
Labeler code: 0054
Product ID: 0054-0389_9f3c9287-0615-4d2e-823d-673b33586e06
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methamphetamine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA203846
Marketing category: ANDA
Marketing start: 2016-12-06
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
A203846-001	METHAMPHETAMINE HYDROCHLORIDE	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA		2015-11-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203846-001	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	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203846-001	METHAMPHETAMINE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2015-11-17	`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	A203846-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203846-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203846-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203846-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203846-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203846-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203846-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203846-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203846-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203846-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203846-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203846-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203846-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203846-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203846-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203846-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203846-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203846-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203846-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203846-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203846-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203846-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203846-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203846-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203846-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203846-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203846-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203846-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203846-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203846-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203846-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203846-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203846-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203846-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203846-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203846-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203846-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203846-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203846-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203846-001	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
90c02ac6-e5e2-4c97-8c68-81e4e389a195	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0054-0389-25	2022-08-05	C162847	48780-1	e4f33bdf-b17e-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use METHAMPHETAMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHAMPHETAMINE HYDROCHLORIDE TABLETS. METHAMPHETAMINE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1943
0054-0389-25	2022-07-29	C162847	48780-1	e4f33bdf-b17e-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use METHAMPHETAMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHAMPHETAMINE HYDROCHLORIDE TABLETS. METHAMPHETAMINE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1943

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0054-0389-25	Methamphetamine Hydrochloride	100 in 1 BOTTLE	TABLET	100		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0389-25	EA - Each	0054-0389	1b222e21-829c-4375-a50d-850d994d301a	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-0389	METHAMPHETAMINE HYDROCHLORIDE TABLET [HIKMA PHARMACEUTICALS USA INC.]	14	Current NDC, Legacy NDC, 1 package rows	20250523_90c02ac6-e5e2-4c97-8c68-81e4e389a195.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methamphetamine Hydrochloride	METHAMPHETAMINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	90c02ac6-e5e2-4c97-8c68-81e4e389a195	2024-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203846 application number: ANDA203846 ndc (product): 0054-0389

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	90c02ac6-e5e2-4c97-8c68-81e4e389a195	14
977860	methamphetamine hydrochloride 5 MG Oral Tablet	SCD	90c02ac6-e5e2-4c97-8c68-81e4e389a195	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0389-25	00054038925	100 TABLET in 1 BOTTLE (0054-0389-25)	100 tablet	2016-12-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methamphetamine Hydrochloride	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2024-09-30	HUMAN PRESCRIPTION DRUG LABEL	14