Home NDC 49702-222 ZIAGEN
Product NDC 49702-222
11-digit product format 497020222
Labeler code 49702
Product ID 49702-222_b0a93ca3-a511-4567-8875-24abb03dd28c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name abacavir sulfate
Dosage form SOLUTION
Route ORAL
Labeler ViiV Healthcare Company
Application NDA020978
Marketing category NDA
Marketing start 1999-01-28
Substance ABACAVIR SULFATE
Active strength 20 mg/mL
Pharmacologic classes Cytochrome P450 1A1 Inhibitors [MoA], 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 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 N020978-001 ZIAGEN ABACAVIR SULFATE EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020978-001 AA
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 · 42 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 2026-08-18 06:07:40 2026-07 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N020978-001 6641843 2019-02-04 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020978-001 6641843*PED 2019-08-04 Pediatric extension 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N020978-001 6641843 2019-02-04 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020978-001 6641843*PED 2019-08-04 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020978-001 6641843 2019-02-04 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020978-001 6641843*PED 2019-08-04 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020978-001 6641843 2019-02-04 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020978-001 6641843*PED 2019-08-04 Pediatric extension ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base ZIAGEN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ABACAVIR SULFATE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J220T4J9Q2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 213461 Internal RxNorm lookup 242680 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 49702-222-48 ZIAGEN 1 in 1 CARTON SOLUTION 1 32 49702-222-48 ZIAGEN 240 mL in 1 BOTTLE SOLUTION 240 32
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ABACAVIR SULFATE ACTIVE INGREDIENT J220T4J9Q2 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 ABACAVIR ACTIVE MOIETY WR2TIP26VS ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 SORBITOL INACTIVE INGREDIENT 506T60A25R ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 WATER INACTIVE INGREDIENT 059QF0KO0R ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49702-222 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 31 Current NDC, Legacy NDC, 2 package rows 20240608_ca73b519-015a-436d-aa3c-af53492825a1.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 ZIAGEN ABACAVIR SULFATE ViiV Healthcare Company ca73b519-015a-436d-aa3c-af53492825a1 2023-09-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020978 application number: NDA020978 ndc (product): 49702-222
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 49702-222-48 49702022248 1 BOTTLE in 1 CARTON (49702-222-48) / 240 mL in 1 BOTTLE 1 bottle 1999-01-28 0000-00-00 No No Current