Androgel
- Product NDC
- 0051-8425
- Requested package NDC
- 0051-8425-30
- 11-digit product format
- 000518425
- Labeler code
- 0051
- Product ID
- 0051-8425_2e54dd8d-cf81-4c69-ad15-fa24f47dd3da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Testosterone
- Dosage form
- GEL
- Route
- TRANSDERMAL
- Labeler
- AbbVie Inc.
- Application
- NDA021015
- Marketing category
- NDA
- Marketing start
- 2011-03-14
- Marketing end
- 2023-03-01
- Substance
- TESTOSTERONE
- Active strength
- 10 mg/g
- Pharmacologic classes
- Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 package | package | 0051-8425 | 0051-8425-30 | D | Discontinued by firm | 2026-08-03 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021015-001 | ANDROGEL | TESTOSTERONE | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 |
| N021015-002 | ANDROGEL | TESTOSTERONE | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 |
| N021015-003 | ANDROGEL | TESTOSTERONE | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021015-001 | AB1 |
| N021015-002 | AB1 |
| N021015-003 | AB1 |
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 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2000-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2000-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | RLD | 2003-09-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | AB1 | RLD | 2000-02-28 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | AB1 | RLD | 2003-09-26 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2000-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2000-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | RLD | 2003-09-26 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2000-02-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2000-02-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | RLD | 2003-09-26 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2000-02-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2000-02-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | RLD | 2003-09-26 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2000-02-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021015-002 | ANDROGEL | 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2000-02-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021015-003 | ANDROGEL | 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED / TRANSDERMAL | RLD | 2003-09-26 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021015-001 | ANDROGEL | 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TRANSDERMAL | RLD | 2000-02-28 | 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 | N021015-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021015-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021015-003 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021015-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021015-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021015-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021015-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021015-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021015-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021015-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021015-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021015-003 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021015-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021015-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021015-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021015-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021015-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021015-003 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021015-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021015-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021015-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021015-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021015-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021015-003 | AB1 | 1 | d8e5a09893c0… |
| 2019-12-13 00:20 UTC | 2019-12 | N021015-001 | AB1 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021015-002 | AB1 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021015-003 | AB | 1 | 74a2ff9319b5… |
| 2021-12-28 21:50 UTC | 2021-12 | N021015-001 | AB1 | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021015-002 | AB1 | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-001 | AB1 | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-002 | AB1 | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021015-001 | AB1 | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021015-002 | AB1 | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021015-001 | AB1 | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021015-002 | AB1 | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021015-001 | AB1 | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021015-002 | AB1 | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021015-001 | AB1 | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021015-002 | AB1 | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021015-003 | AB | 1 | 3f01610625f2… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021015-001 | 6503894 | 2020-08-30 | U-490 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-001 | 9125816 | 2020-08-30 | U-490 | 2015-09-14 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021015-001 | 9132089 | 2020-08-30 | U-490 | 2015-09-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021015-001 | 6503894*PED | 2021-03-01 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-001 | 9125816*PED | 2021-03-02 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-001 | 9132089*PED | 2021-03-02 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-002 | 6503894 | 2020-08-30 | U-490 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-002 | 9125816 | 2020-08-30 | U-490 | 2015-09-14 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021015-002 | 9132089 | 2020-08-30 | U-490 | 2015-09-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021015-002 | 6503894*PED | 2021-03-01 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-002 | 9125816*PED | 2021-03-02 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-002 | 9132089*PED | 2021-03-02 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-003 | 6503894 | 2020-08-30 | U-490 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-003 | 9125816 | 2020-08-30 | U-490 | 2015-09-14 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021015-003 | 9132089 | 2020-08-30 | U-490 | 2015-09-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021015-003 | 6503894*PED | 2021-03-01 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-003 | 9125816*PED | 2021-03-02 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021015-003 | 9132089*PED | 2021-03-02 | Pediatric extension | 74a2ff9319b5… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021015-001 | 6503894*PED | 2021-03-01 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021015-001 | 9125816*PED | 2021-03-02 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021015-001 | 9132089*PED | 2021-03-02 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021015-002 | 6503894*PED | 2021-03-01 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021015-002 | 9125816*PED | 2021-03-02 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021015-002 | 9132089*PED | 2021-03-02 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021015-003 | 6503894*PED | 2021-03-01 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021015-003 | 9125816*PED | 2021-03-02 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021015-003 | 9132089*PED | 2021-03-02 | Pediatric extension | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-001 | 6503894*PED | 2021-03-01 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-001 | 9125816*PED | 2021-03-02 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-001 | 9132089*PED | 2021-03-02 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-002 | 6503894*PED | 2021-03-01 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-002 | 9125816*PED | 2021-03-02 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-002 | 9132089*PED | 2021-03-02 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-003 | 6503894*PED | 2021-03-01 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-003 | 9125816*PED | 2021-03-02 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021015-003 | 9132089*PED | 2021-03-02 | Pediatric extension | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021015-001 | 6503894*PED | 2021-03-01 | Pediatric extension | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021015-001 | 9125816*PED | 2021-03-02 | Pediatric extension | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021015-001 | 9132089*PED | 2021-03-02 | Pediatric extension | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021015-002 | 6503894*PED | 2021-03-01 | Pediatric extension | 5aa47cf7b7d7… |
DailyMed Product Concepts#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0051-8425-01 | GM - Gram | 0051-8425 | d2b26488-d5cb-4902-8157-bf447698b6f9 | 1 | 2012-07-24 |
| 0051-8425-30 | GM - Gram | 0051-8425 | 3c45a762-3612-41af-9d31-59c0f905053c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| testosterone | ACTIVE INGREDIENT | 3XMK78S47O | ANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.] | 78 | |
| testosterone | ACTIVE MOIETY | 3XMK78S47O | ANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.] | 78 | |
| alcohol | INACTIVE INGREDIENT | 3K9958V90M | ANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.] | 78 | |
| carbomer homopolymer type C | INACTIVE INGREDIENT | 4Q93RCW27E | ANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.] | 78 | |
| isopropyl myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | ANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.] | 78 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | ANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.] | 78 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | ANDROGEL (TESTOSTERONE) GEL [ABBVIE INC.] | 78 | |
| testosterone | ACTIVE INGREDIENT | 3XMK78S47O | ANDROGEL (TESTOSTERONE) GEL [PHYSICIANS TOTAL CARE, INC.] | 3 | |
| testosterone | ACTIVE MOIETY | 3XMK78S47O | ANDROGEL (TESTOSTERONE) GEL [PHYSICIANS TOTAL CARE, INC.] | 3 |
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 | 68b2375d-0365-4797-bc3d-63531c9f42fd | 2024-12-01 | Boxed warning, Warnings, Adverse reactions | 021015 NDA021015 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1597074 | AndroGel 1 % (12.5 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUAT | PSN | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
| 1597124 | AndroGel 1 % (25MG / 2.5GM) Transdermal Gel | PSN | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
| 1597130 | AndroGel 1 % (50MG / 5GM) Transdermal Gel | PSN | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
| 1596780 | testosterone 1 % (12.5 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUAT | PSN | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
| 1597123 | testosterone 1 % (25 MG / 2.5 GM) Transdermal Gel | PSN | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
| 1597129 | testosterone 1 % (50 MG / 5 GM) Transdermal Gel | PSN | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
| 1597124 | 2500 MG testosterone 0.01 MG/MG Topical Gel [Androgel] | SBD | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
| 1597130 | 5000 MG testosterone 0.01 MG/MG Topical Gel [Androgel] | SBD | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
| 1597074 | 60 ACTUAT testosterone 12.5 MG/ACTUAT Topical Gel [Androgel] | SBD | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
| 1597123 | 2500 MG testosterone 0.01 MG/MG Topical Gel | SCD | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
| 1597129 | 5000 MG testosterone 0.01 MG/MG Topical Gel | SCD | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
| 1596780 | 60 ACTUAT testosterone 12.5 MG/ACTUAT Topical Gel | SCD | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
| 1597124 | 2500 MG Androgel 0.01 MG/MG Topical Gel | SY | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
| 1597130 | 5000 MG Androgel 0.01 MG/MG Topical Gel | SY | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
| 1597074 | AndroGel 1 % (12.5 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUAT | SY | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
| 1597124 | Androgel 1 % Transdermal Gel, 2.5 GM | SY | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
| 1597130 | Androgel 1 % Transdermal Gel, 5 GM | SY | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
| 1597123 | testosterone 1 % Transdermal Gel, 2.5 GM | SY | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
| 1596780 | testosterone 12.5 MG/ACTUAT Transdermal Gel Pump, 60 ACTUAT | SY | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
| 1597129 | testosterone 50 MG Transdermal Gel, 5 GM | SY | d466910c-9a76-44e8-8759-4717ec2c591f | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0051-8425-30 | 00051842530 | 30 PACKET in 1 CARTON (0051-8425-30) > 2.5 g in 1 PACKET (0051-8425-01) | 30 packet | 2011-03-14 | 2023-03-01 | No | No | Current |