Panzyga
- Product NDC
- 68982-820
- 11-digit product format
- 689820820
- Labeler code
- 68982
- Product ID
- 68982-820_9f78508b-2dbf-5d6e-85e8-4f60d87bc562
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- immune globulin intravenous (human)
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Octapharma USA Inc
- Application
- BLA125587
- Marketing category
- BLA
- Marketing start
- 2018-11-12
- Marketing end
- 0000-00-00
- Substance
- HUMAN IMMUNOGLOBULIN G
- Active strength
- 100 mg/mL
- Pharmacologic classes
- Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 | 68982-820 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 68982-820 | 68982-820-01 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 68982-820 | 68982-820-02 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 68982-820 | 68982-820-03 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 68982-820 | 68982-820-04 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 68982-820 | 68982-820-05 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 68982-820 | 68982-820-06 | I | Inactivated by FDA | 2026-08-17 |
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 | 68982-820-04 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68982-820-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68982-820-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68982-820-06 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68982-820-03 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68982-820-05 | 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 | 68982-820-04 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68982-820-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68982-820-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68982-820-06 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68982-820-03 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68982-820-05 | 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 | 68982-820-04 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68982-820-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68982-820-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68982-820-06 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68982-820-03 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68982-820-05 | 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 | 68982-820-04 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68982-820-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68982-820-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68982-820-06 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68982-820-03 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68982-820-05 | 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 | 68982-820-04 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68982-820-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68982-820-02 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68982-820-06 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68982-820-03 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68982-820-05 | 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 | 68982-820-04 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68982-820-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68982-820-02 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68982-820-06 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68982-820-03 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68982-820-05 | 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 | 68982-820-04 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68982-820-01 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68982-820-02 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68982-820-06 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68982-820-03 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68982-820-05 | 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 | 68982-820-04 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68982-820-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68982-820-02 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68982-820-06 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68982-820-03 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68982-820-05 | 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 | 68982-820-04 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68982-820-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68982-820-02 | 0efc9e666f02… | f202fb6c5f17… |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68982-820-01 | Panzyga | 1 in 1 CARTON | SOLUTION | 1 | 11 | |
| 68982-820-02 | Panzyga | 1 in 1 CARTON | SOLUTION | 1 | 11 | |
| 68982-820-03 | Panzyga | 1 in 1 CARTON | SOLUTION | 1 | 11 | |
| 68982-820-04 | Panzyga | 1 in 1 CARTON | SOLUTION | 1 | 11 | |
| 68982-820-05 | Panzyga | 1 in 1 CARTON | SOLUTION | 1 | 11 | |
| 68982-820-06 | Panzyga | 1 in 1 CARTON | SOLUTION | 1 | 11 | |
| 68982-820-81 | Panzyga | 10 mL in 1 BOTTLE, GLASS | SOLUTION | 10 | 11 | |
| 68982-820-82 | Panzyga | 25 mL in 1 BOTTLE, GLASS | SOLUTION | 25 | 11 | |
| 68982-820-83 | Panzyga | 50 mL in 1 BOTTLE, GLASS | SOLUTION | 50 | 11 | |
| 68982-820-84 | Panzyga | 100 mL in 1 BOTTLE, GLASS | SOLUTION | 100 | 11 | |
| 68982-820-85 | Panzyga | 200 mL in 1 BOTTLE, GLASS | SOLUTION | 200 | 11 | |
| 68982-820-86 | Panzyga | 300 mL in 1 BOTTLE, GLASS | SOLUTION | 300 | 11 |
DailyMed Billing Units#
DailyMed Dashboard NDC Coverage#
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 125587 | Panzyga | Immune Globulin Intravenous (Human)-ifas | 351(a) | Rx | 2026-08-01 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2102435 | immune globulin intravenous (human) - ifas 10 % in 10 ML Injection | PSN | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102463 | immune globulin intravenous (human) - ifas 10 % in 100 ML Injection | PSN | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102469 | immune globulin intravenous (human) - ifas 10 % in 200 ML Injection | PSN | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102455 | immune globulin intravenous (human) - ifas 10 % in 25 ML Injection | PSN | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102471 | immune globulin intravenous (human) - ifas 10 % in 300 ML Injection | PSN | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102459 | immune globulin intravenous (human) - ifas 10 % in 50 ML Injection | PSN | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102440 | panzyga 10 % in 10 ML Injection | PSN | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102464 | panzyga 10 % in 100 ML Injection | PSN | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102470 | panzyga 10 % in 200 ML Injection | PSN | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102456 | panzyga 10 % in 25 ML Injection | PSN | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102472 | panzyga 10 % in 300 ML Injection | PSN | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102460 | panzyga 10 % in 50 ML Injection | PSN | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102440 | 10 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga] | SBD | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102464 | 100 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga] | SBD | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102470 | 200 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga] | SBD | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102456 | 25 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga] | SBD | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102472 | 300 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga] | SBD | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102460 | 50 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection [Panzyga] | SBD | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102435 | 10 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection | SCD | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102463 | 100 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection | SCD | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102469 | 200 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection | SCD | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102455 | 25 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection | SCD | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102471 | 300 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection | SCD | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102459 | 50 ML immune globulin intravenous (human) - ifas 100 MG/ML Injection | SCD | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102440 | 10 ML Panzyga 100 MG/ML Injection | SY | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102464 | 100 ML Panzyga 100 MG/ML Injection | SY | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102470 | 200 ML Panzyga 100 MG/ML Injection | SY | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102456 | 25 ML Panzyga 100 MG/ML Injection | SY | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102472 | 300 ML Panzyga 100 MG/ML Injection | SY | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102460 | 50 ML Panzyga 100 MG/ML Injection | SY | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102435 | immune globulin intravenous (human) - ifas 10 % per 10 ML Injection | SY | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102463 | immune globulin intravenous (human) - ifas 10 % per 100 ML Injection | SY | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102469 | immune globulin intravenous (human) - ifas 10 % per 200 ML Injection | SY | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102455 | immune globulin intravenous (human) - ifas 10 % per 25 ML Injection | SY | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102471 | immune globulin intravenous (human) - ifas 10 % per 300 ML Injection | SY | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102459 | immune globulin intravenous (human) - ifas 10 % per 50 ML Injection | SY | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102440 | Panzyga 10 % per 10 ML Injection | SY | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102464 | Panzyga 10 % per 100 ML Injection | SY | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102470 | Panzyga 10 % per 200 ML Injection | SY | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102456 | Panzyga 10 % per 25 ML Injection | SY | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102472 | Panzyga 10 % per 300 ML Injection | SY | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
| 2102460 | Panzyga 10 % per 50 ML Injection | SY | 68a5ee5f-0352-b3ae-3321-c0a22947a31d | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68982-820-01 | 68982082001 | 1 BOTTLE, GLASS in 1 CARTON (68982-820-01) > 10 mL in 1 BOTTLE, GLASS (68982-820-81) | 2018-11-12 | 0000-00-00 | No | No | Current | |
| 68982-820-02 | 68982082002 | 1 BOTTLE, GLASS in 1 CARTON (68982-820-02) > 25 mL in 1 BOTTLE, GLASS (68982-820-82) | 2018-11-12 | 0000-00-00 | No | No | Current | |
| 68982-820-03 | 68982082003 | 1 BOTTLE, GLASS in 1 CARTON (68982-820-03) > 50 mL in 1 BOTTLE, GLASS (68982-820-83) | 2018-11-12 | 0000-00-00 | No | No | Current | |
| 68982-820-04 | 68982082004 | 1 BOTTLE, GLASS in 1 CARTON (68982-820-04) > 100 mL in 1 BOTTLE, GLASS (68982-820-84) | 2018-11-12 | 0000-00-00 | No | No | Current | |
| 68982-820-05 | 68982082005 | 1 BOTTLE, GLASS in 1 CARTON (68982-820-05) > 200 mL in 1 BOTTLE, GLASS (68982-820-85) | 2018-11-12 | 0000-00-00 | No | No | Current | |
| 68982-820-06 | 68982082006 | 1 BOTTLE, GLASS in 1 CARTON (68982-820-06) > 300 mL in 1 BOTTLE, GLASS (68982-820-86) | 2018-11-12 | 0000-00-00 | No | No | Current | |
| 68982-820-81 | 68982082081 | 10 mL in 1 BOTTLE, GLASS | 10 ml | Historical | ||||
| 68982-820-82 | 68982082082 | 25 mL in 1 BOTTLE, GLASS | 25 ml | Historical | ||||
| 68982-820-83 | 68982082083 | 50 mL in 1 BOTTLE, GLASS | 50 ml | Historical | ||||
| 68982-820-84 | 68982082084 | 100 mL in 1 BOTTLE, GLASS | 100 ml | Historical | ||||
| 68982-820-85 | 68982082085 | 200 mL in 1 BOTTLE, GLASS | 200 ml | Historical | ||||
| 68982-820-86 | 68982082086 | 300 mL in 1 BOTTLE, GLASS | 300 ml | Historical |