TESTOSTERONE

Product NDC: 62332-488
11-digit product format: 623320488
Labeler code: 62332
Product ID: 62332-488_5ce13b01-78d1-49fa-80c9-6e54d0774e14
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TESTOSTERONE
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Alembic Pharmaceuticals Inc.
Application: ANDA212882
Marketing category: ANDA
Marketing start: 2021-12-08
Substance: TESTOSTERONE
Active strength: 30 mg/1.5mL
Pharmacologic classes: Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule: CIII
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 42.

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
A212882-001	TESTOSTERONE	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL			2021-06-14

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL	AT	2021-06-14	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212882-001	TESTOSTERONE	30MG/1.5ML ACTUATION	SOLUTION, METERED / TRANSDERMAL		2021-06-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A212882-001	AT	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TESTOSTERONE	30 mg/1.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3XMK78S47O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1599949	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
e39289aa-681c-47ec-9461-52e7f17e5d71	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2db4fc38-a116-b0ab-3dae-57df54e5f212	Product name	2	20250121
386d1b2a-e9b7-0c83-111f-2a77b92895b3	Product name	5	20240422
7d55b53c-798b-47ae-992b-3921493a8303	Product name	1	20230322
8d753fd6-75b2-4f12-bcbf-339392960afa	Product name	1	20230303
4fbda828-a5be-46fe-83ec-a88da4359919	Product name	1	20230104
93cc9bee-8bdc-273d-ec7f-c2c52535317a	Product name	7	20210902
a6389cd1-36d1-4b5c-9934-1139bee93605	Product name	5	20210601
f4f0889f-ee8b-471f-9a37-02a035280637	Product name	1	20200122
09e1afd3-f431-4380-82c5-438884c25615	Product name	1	20190111
a6389cd1-36d1-4b5c-9934-1139bee93605	Product name	3	20171212
502efed8-01a5-ef6a-61c6-fe8302b6e26b	Product name	2	20171113
8b700cfd-17dd-41a2-90f5-a80ae8a989a2	Product name	1	20171113
9ce0e503-4ae7-2c6a-39ae-85285c29db68	Product name	2	20171113
96bdf4b3-71cd-433d-9723-89e50f852992	Product name	1	20150810
ed2e617f-f28a-1df1-f9fc-c79702f31271	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62332-488-11	TESTOSTERONE	110 mL in 1 BOTTLE, WITH APPLICATOR	SOLUTION	110		9
62332-488-11	TESTOSTERONE	1 in 1 CARTON	SOLUTION	1		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62332-488	TESTOSTERONE SOLUTION [ALEMBIC PHARMACEUTICALS INC.]	8	Current NDC, Legacy NDC, 2 package rows	20231209_e39289aa-681c-47ec-9461-52e7f17e5d71.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
TESTOSTERONE	TESTOSTERONE	Alembic Pharmaceuticals Inc.	e39289aa-681c-47ec-9461-52e7f17e5d71	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212882 application number: ANDA212882 ndc (product): 62332-488

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3XMK78S47O	TESTOSTERONE	58-22-0	TESTOSTERONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1599949	testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUAT	PSN	e39289aa-681c-47ec-9461-52e7f17e5d71	9
1599949	60 ACTUAT testosterone 30 MG/ACTUAT Topical Solution	SCD	e39289aa-681c-47ec-9461-52e7f17e5d71	9
1599949	60 ACTUAT testosterone 30 MG/1.5 ML ACTUAT Topical Solution	SY	e39289aa-681c-47ec-9461-52e7f17e5d71	9
1599949	testosterone (as testosterone propionate) 2 % Topical Solution	SY	e39289aa-681c-47ec-9461-52e7f17e5d71	9
1599949	testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUAT	SY	e39289aa-681c-47ec-9461-52e7f17e5d71	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
62332-488-11	62332048811	1 BOTTLE, WITH APPLICATOR in 1 CARTON (62332-488-11) / 110 mL in 1 BOTTLE, WITH APPLICATOR	2021-12-08	0000-00-00	No	No	Current