Home NDC 49702-213 RETROVIR
Product NDC 49702-213
11-digit product format 497020213
Labeler code 49702
Product ID 49702-213_01ba4f9b-3d72-4bc2-bae1-ecb13a8b845a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zidovudine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler ViiV Healthcare Company
Application NDA019951
Marketing category NDA
Marketing start 2010-11-04
Substance ZIDOVUDINE
Active strength 10 mg/mL
Pharmacologic classes Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]
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 N019951-001 RETROVIR ZIDOVUDINE 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02
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 RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1990-02-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1990-02-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1990-02-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1990-02-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1990-02-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1990-02-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1990-02-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION AP RLD, RS 1990-02-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019951-001 RETROVIR 10MG/ML INJECTABLE / INJECTION RLD, RS 1990-02-02 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base RETROVIR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZIDOVUDINE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4B9XT59T7S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 108396 Internal RxNorm lookup 198352 Internal RxNorm lookup 201907 Internal RxNorm lookup 204534 Internal RxNorm lookup 755298 Internal RxNorm lookup 756209 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49702-213-01 RETROVIR 20 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 20 32 49702-213-26 RETROVIR 5 in 1 CARTON INJECTION, SOLUTION 5 32
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZIDOVUDINE ACTIVE INGREDIENT 4B9XT59T7S RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SYRUP RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 12 ZIDOVUDINE ACTIVE MOIETY 4B9XT59T7S RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SYRUP RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SYRUP RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 12 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SYRUP RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 12 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SYRUP RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 12 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SYRUP RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 12 GELATIN INACTIVE INGREDIENT 2G86QN327L RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SYRUP RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 12 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SYRUP RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 12 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SYRUP RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 12 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SYRUP RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SYRUP RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 12 SHELLAC INACTIVE INGREDIENT 46N107B71O RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SYRUP RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 12 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SYRUP RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 12 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SYRUP RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 12 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SYRUP RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 12 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SYRUP RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 12 SUCROSE INACTIVE INGREDIENT C151H8M554 RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SYRUP RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SYRUP RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 12 WATER INACTIVE INGREDIENT 059QF0KO0R RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SYRUP RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49702-213 RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SOLUTION RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY] 31 Current NDC, Legacy NDC, 2 package rows 20241204_6df09f15-b102-431c-adde-d7aeef6f5d84.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49702-213-01 49702021301 20 mL in 1 VIAL, SINGLE-USE 20 ml Historical 49702-213-26 49702021326 5 VIAL, SINGLE-USE in 1 CARTON (49702-213-26) / 20 mL in 1 VIAL, SINGLE-USE (49702-213-01) 2016-12-01 0000-00-00 No No Current