Testosterone
- Product NDC
- 68382-362
- 11-digit product format
- 683820362
- Labeler code
- 68382
- Product ID
- 68382-362_8666360e-663b-404a-ad04-d82f88b33fb2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Testosterone
- Dosage form
- GEL
- Route
- TRANSDERMAL
- Labeler
- Zydus Pharmaceuticals USA Inc
- Application
- NDA022309
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2018-10-12
- Marketing end
- 0000-00-00
- Substance
- TESTOSTERONE
- Active strength
- 16 mg/g
- Pharmacologic classes
- Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
- DEA schedule
- CIII
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68382-362 | D | Discontinued by firm | 2026-08-07 | ||
| excluded package | package | 68382-362 | 68382-362-11 | D | Discontinued by firm | 2026-08-07 | |
| excluded package | package | 68382-362 | 68382-362-14 | D | Discontinued by firm | 2026-08-07 | |
| excluded package | package | 68382-362 | 68382-362-15 | D | Discontinued by firm | 2026-08-07 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68382-362-14 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68382-362-11 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68382-362-15 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68382-362-14 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68382-362-11 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68382-362-15 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68382-362-14 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68382-362-11 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68382-362-15 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68382-362-14 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68382-362-11 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68382-362-15 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68382-362-14 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68382-362-11 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68382-362-15 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68382-362-14 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68382-362-11 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68382-362-15 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68382-362-14 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68382-362-11 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68382-362-15 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68382-362-14 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68382-362-11 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68382-362-15 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68382-362-14 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68382-362-11 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68382-362-15 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68382-362-14 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68382-362-11 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68382-362-15 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68382-362-14 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68382-362-11 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68382-362-15 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68382-362-14 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68382-362-11 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68382-362-15 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022309-001 | ANDROGEL | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 |
| N022309-002 | ANDROGEL | TESTOSTERONE | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 |
| N022309-003 | ANDROGEL | TESTOSTERONE | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022309-001 | AB |
| N022309-002 | AB2 |
| N022309-003 | AB2 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022309-001 | 8466136 | 2026-10-12 | Drug product | 2013-06-24 | |
| N022309-001 | 8466137 | 2026-10-12 | U-1103 | 2013-06-24 | |
| N022309-001 | 8466138 | 2026-10-12 | U-1103 | 2013-06-24 | |
| N022309-001 | 8486925 | 2026-10-12 | Drug product | 2013-07-19 | |
| N022309-001 | 8729057 | 2026-10-12 | Drug product | ||
| N022309-001 | 8741881 | 2026-10-12 | U-1103 | 2014-06-25 | |
| N022309-001 | 8754070 | 2026-10-12 | Drug product | 2014-07-16 | |
| N022309-001 | 8759329 | 2026-10-12 | Drug product | 2014-07-09 | |
| N022309-002 | 8466136 | 2026-10-12 | Drug product | 2013-06-24 | |
| N022309-002 | 8466137 | 2026-10-12 | U-1103 | 2013-06-24 | |
| N022309-002 | 8466138 | 2026-10-12 | U-1103 | 2013-06-24 | |
| N022309-002 | 8486925 | 2026-10-12 | Drug product | 2013-07-19 | |
| N022309-002 | 8729057 | 2026-10-12 | Drug product | 2014-06-13 | |
| N022309-002 | 8741881 | 2026-10-12 | U-1103 | 2014-06-25 | |
| N022309-002 | 8754070 | 2026-10-12 | Drug product | 2014-07-16 | |
| N022309-002 | 8759329 | 2026-10-12 | Drug product | 2014-07-09 | |
| N022309-003 | 8466136 | 2026-10-12 | Drug product | 2013-06-24 | |
| N022309-003 | 8466137 | 2026-10-12 | U-1103 | 2013-06-24 | |
| N022309-003 | 8466138 | 2026-10-12 | U-1103 | 2013-06-24 | |
| N022309-003 | 8486925 | 2026-10-12 | Drug product | 2013-07-19 | |
| N022309-003 | 8729057 | 2026-10-12 | Drug product | 2014-06-13 | |
| N022309-003 | 8741881 | 2026-10-12 | U-1103 | 2014-06-25 | |
| N022309-003 | 8754070 | 2026-10-12 | Drug product | 2014-07-16 | |
| N022309-003 | 8759329 | 2026-10-12 | Drug product | 2014-07-09 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2012-09-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2012-09-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2012-09-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB2 | RLD | 2012-09-07 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2012-09-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2012-09-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2012-09-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2012-09-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2012-09-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2012-09-07 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022309-002 | ANDROGEL | 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2012-09-07 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022309-003 | ANDROGEL | 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2012-09-07 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022309-001 | ANDROGEL | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED / TRANSDERMAL | AB | RLD, RS | 2011-04-29 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022309-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-002 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-003 | AB2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-002 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-003 | AB2 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022309-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022309-002 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022309-003 | AB2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022309-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022309-002 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022309-003 | AB2 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022309-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022309-002 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022309-003 | AB2 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022309-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022309-002 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022309-003 | AB2 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022309-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022309-002 | AB2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022309-003 | AB2 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022309-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022309-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022309-003 | AB2 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022309-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022309-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022309-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022309-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022309-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022309-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022309-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022309-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022309-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022309-002 | AB2 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022309-003 | AB2 | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022309-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022309-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N022309-002 | AB2 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N022309-003 | AB2 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022309-001 | AB | 1 | 87673890dc5c… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022309-001 | 8466136 | 2026-10-12 | Drug product | 2013-06-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-001 | 8466137 | 2026-10-12 | U-1103 | 2013-06-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-001 | 8466138 | 2026-10-12 | U-1103 | 2013-06-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-001 | 8486925 | 2026-10-12 | Drug product | 2013-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-001 | 8729057 | 2026-10-12 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022309-001 | 8741881 | 2026-10-12 | U-1103 | 2014-06-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-001 | 8754070 | 2026-10-12 | Drug product | 2014-07-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-001 | 8759329 | 2026-10-12 | Drug product | 2014-07-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-002 | 8466136 | 2026-10-12 | Drug product | 2013-06-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-002 | 8466137 | 2026-10-12 | U-1103 | 2013-06-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-002 | 8466138 | 2026-10-12 | U-1103 | 2013-06-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-002 | 8486925 | 2026-10-12 | Drug product | 2013-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-002 | 8729057 | 2026-10-12 | Drug product | 2014-06-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-002 | 8741881 | 2026-10-12 | U-1103 | 2014-06-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-002 | 8754070 | 2026-10-12 | Drug product | 2014-07-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-002 | 8759329 | 2026-10-12 | Drug product | 2014-07-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-003 | 8466136 | 2026-10-12 | Drug product | 2013-06-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-003 | 8466137 | 2026-10-12 | U-1103 | 2013-06-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-003 | 8466138 | 2026-10-12 | U-1103 | 2013-06-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-003 | 8486925 | 2026-10-12 | Drug product | 2013-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-003 | 8729057 | 2026-10-12 | Drug product | 2014-06-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-003 | 8741881 | 2026-10-12 | U-1103 | 2014-06-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-003 | 8754070 | 2026-10-12 | Drug product | 2014-07-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022309-003 | 8759329 | 2026-10-12 | Drug product | 2014-07-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-001 | 8466136 | 2026-10-12 | Drug product | 2013-06-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-001 | 8466137 | 2026-10-12 | U-1103 | 2013-06-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-001 | 8466138 | 2026-10-12 | U-1103 | 2013-06-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-001 | 8486925 | 2026-10-12 | Drug product | 2013-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-001 | 8729057 | 2026-10-12 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-001 | 8741881 | 2026-10-12 | U-1103 | 2014-06-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-001 | 8754070 | 2026-10-12 | Drug product | 2014-07-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-001 | 8759329 | 2026-10-12 | Drug product | 2014-07-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-002 | 8466136 | 2026-10-12 | Drug product | 2013-06-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-002 | 8466137 | 2026-10-12 | U-1103 | 2013-06-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-002 | 8466138 | 2026-10-12 | U-1103 | 2013-06-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-002 | 8486925 | 2026-10-12 | Drug product | 2013-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-002 | 8729057 | 2026-10-12 | Drug product | 2014-06-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-002 | 8741881 | 2026-10-12 | U-1103 | 2014-06-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-002 | 8754070 | 2026-10-12 | Drug product | 2014-07-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022309-002 | 8759329 | 2026-10-12 | Drug product | 2014-07-09 | 31067a03dcf5… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68382-362-11 | GM - Gram | 68382-362 | 4a3cd9a6-b2cd-4fdc-872f-44dc791f8b3a | 1 | 2018-11-06 |
| 68382-362-12 | GM - Gram | 68382-362 | b839d9ae-1357-438f-8eeb-25c6035ac6da | 1 | 2018-11-06 |
| 68382-362-13 | GM - Gram | 68382-362 | 6e168ee2-bbba-4f94-befd-57ab0f3d3921 | 1 | 2018-11-06 |
| 68382-362-14 | GM - Gram | 68382-362 | 3d7e2521-3165-4cc9-be86-eb81f81376bb | 1 | 2018-11-06 |
| 68382-362-15 | GM - Gram | 68382-362 | 493b1950-3cbf-4704-9347-a719329be0c2 | 1 | 2018-11-06 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Testosterone | TESTOSTERONE | Prasco Laboratories | 0d84e5a6-11e9-4940-8991-21c611c4c32f | 2024-09-30 | Boxed warning, Warnings, Adverse reactions | 022309 NDA022309 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68382-362-11 | 68382036211 | 1 BOTTLE, PUMP in 1 CARTON (68382-362-11) > 88 g in 1 BOTTLE, PUMP | 2018-10-12 | 0000-00-00 | No | No | Current | |
| 68382-362-14 | 68382036214 | 30 PACKET in 1 CARTON (68382-362-14) > 1.25 g in 1 PACKET (68382-362-12) | 30 packet | 2018-10-12 | 0000-00-00 | No | No | Current |
| 68382-362-15 | 68382036215 | 30 PACKET in 1 CARTON (68382-362-15) > 2.5 g in 1 PACKET (68382-362-13) | 30 packet | 2018-10-12 | 0000-00-00 | No | No | Current |